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Introduction
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ORIGINAL ARTICLE
Year : 2022  |  Volume : 23  |  Issue : 1  |  Page : 31-37
 

Addition of dexmedetomidine and nalbuphine as an adjuvant to ketofol for deep sedation during endoscopic retrograde cholangiopancreatography: A prospective, randomized, double-blind study


1 Department of Anaesthesia and Critical Care, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India
2 SMS Medical College and Hospital, Jaipur, Rajasthan, India
3 Department of Anaesthesia and critical care, AIIMS, Rajkot, Gujrat, India
4 Department of critical care, Apollo Cancer centre, Bilaspur, Madhya Pradesh, India

Date of Submission21-Apr-2021
Date of Decision15-Dec-2021
Date of Acceptance05-Feb-2022
Date of Web Publication23-Mar-2022

Correspondence Address:
Dr. Karuna Sharma
E-704, Krishnangan, New Vidhya Nagar, Sector -4, Hiran Magri, Udaipur, Rajasthan
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/TheIAForum.TheIAForum_69_21

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  Abstract 


Background: Deep sedation has evolved as a better choice against general anesthesia in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). This study was aimed to evaluate the efficacy of dexmedetomidine and nalbuphine as an adjuvant to ketofol based deep sedation in ERCP.
Methods: One hundred patients undergoing ERCP were randomly assigned to receive either IV dexmedetomidine 1 μg/kg (Group D, n = 50) or I. V nalbuphine 0.1 μg/kg (Group N, n = 50), 10 min before ketofol induction. The primary outcome was the total dose of ketofol used for induction and maintenance of deep sedation throughout the procedure. Hemodynamics and respiratory parameters, recovery characteristics, endoscopist's, and anesthetist satisfaction scores were secondary outcomes. P < 0.05 was considered statistically significant.
Results: The dose of ketofol at the time of induction was significantly high in Group N as compared to Group D (P < 0.05). Supplemental dose of ketofol at the time of insertion of endoscope was equivalent in both the groups (P > 0.05) but significantly more number of patients in Group D (n = 19 vs. n = 11, P < 0.05) received supplement for facial pain score >5 compared to patients in Group N, where more patients received supplement for Ramsay Sedation Score <3 (n = 20 vs. n = 11 P < 0.05). Significant decrease in heart rate (HR) and mean arterial pressure from baseline values was found in Group D as compared to Group N (P < 0.001). Group N patients achieved postanesthesia recovery score >12 earlier than Group D (P < 0.001). Anesthetist satisfaction score was more in Group N (P < 0.05).
Conclusion: Dexmedetomidine reduces the total consumption of ketofol and provides smooth hemodynamics whereas Nalbuphine provides better analgesia and early recovery with high anesthetist satisfaction for deep sedation in ERCP.


Keywords: Deep sedation, dexmedetomidine, endoscopic retrograde cholangiopancreatography, ketofol, nalbuphine


How to cite this article:
Alka C, Sharma K, Chaudhary N, Dave M, Pandey N, Gupta S. Addition of dexmedetomidine and nalbuphine as an adjuvant to ketofol for deep sedation during endoscopic retrograde cholangiopancreatography: A prospective, randomized, double-blind study. Indian Anaesth Forum 2022;23:31-7

How to cite this URL:
Alka C, Sharma K, Chaudhary N, Dave M, Pandey N, Gupta S. Addition of dexmedetomidine and nalbuphine as an adjuvant to ketofol for deep sedation during endoscopic retrograde cholangiopancreatography: A prospective, randomized, double-blind study. Indian Anaesth Forum [serial online] 2022 [cited 2022 Oct 3];23:31-7. Available from: http://www.theiaforum.org/text.asp?2022/23/1/31/340486





  Introduction Top


Endoscopic retrograde cholangiopancreatography (ERCP) is a challenging procedure as there is sharing of the airway between anesthesiologists and gastroenterologists. Anesthesia for endoscopic procedures, especially ERCP aims at reducing pain, discomfort, and stress.[1] Conscious sedation, deep sedation, and general anesthesia are some of the options advocated for it which can be individualized. However, in conscious sedation, patient's comfort is sometimes compromised at the cost of safety and failure rate as the procedure can be terminated prematurely due to inadequate level of sedation and inappropriate selection of sedative agents.[2] General anesthesia is safe, but it requires more use of resources, time, and overall cost of the procedure increases, while providing it in remote locations outside the operative room and managing complications may be more challenging. Hence, deep sedation has evolved as a better choice to get a good success rate as patients can respond following repeated or painful stimulation.[3]

Propofol and ketamine, when administered as a sole anesthetic require larger doses which can compromise cardiopulmonary status and propofol may produce the inadequate level of analgesia.[4] It is postulated that combining propofol and ketamine (ketofol) may preserve sedative and analgesic efficacy while minimizing the doses of individual drugs and their respective adverse effects. Since they have opposing cardiovascular effects, they provide more stable hemodynamic and respiratory profiles that were tested and found to be true in the group of patients receiving GA.[5] The addition of adjuvants (analgesic or sedative agent) can further reduce the dose of two agents to produce the desired level of deep sedation while minimizing the side effects.

This study was designed to assess the effects of dexmedetomidine and nalbuphine as an adjuvant to ketofol-based deep sedation for ERCP. The primary outcome was the total dose of ketofol used for induction and maintenance of deep sedation throughout the procedure, whereas hemodynamic and respiratory parameters, recovery characteristics, endoscopist, and anesthetist satisfaction scores were secondary outcomes.


  Methods Top


After obtaining approval from the institutional research ethics board; (GU/HREC/EC/2017/1495, dated December 12, 2017) and written informed consent from all the patients, this prospective randomized, double-blinded clinical study was conducted for one and a half year between January 2018 and June 2019. One hundred patients of the American Society of Anesthesiologists (ASA) physical status grade I-III between the age group of 18–60 years of either sex undergoing diagnostic or therapeutic ERCP were enrolled in the study. Patients whose baseline oxygen saturation (SpO2) was <90%, body mass index (BMI) >30 kg/m2, mechanically ventilated patients, pre-existing cardiac disease, asthma, and severe renal or hepatic dysfunction were excluded from the study. Other exclusion criteria included pregnancy, patients with known allergy to study drugs, and patients' refusal.

Eligible patients were randomized 1:1 using computer-generated series into two groups of 50 each. Allocation concealment was done using a sealed opaque envelope having only one number on the outer side. The study drugs were prepared by the assistant who was not involved in data collection. The anesthesiologist who administered the drugs and recorded the parameters was blinded to the randomization of the prepared drugs. Group D received intravenous (IV) dexmedetomidine 1 μg/kg while Group N received IV nalbuphine 0.1 mg/kg, both the drugs were diluted to 10 ml of 0.9% normal saline. All patients in Group N and D received a standard dose of ketofol (1:1), ketamine (100 mg: 2 ml) + propofol (100 mg: 10 ml) diluted to 20 ml normal saline.

A detailed preoperative checkup including general and systemic examination of the patient was carried out. On arrival to the endoscopy room, 20G IV cannula was secured on nondominant hand, Ringer Lactate drip was started (6–8 ml/kg/h) and all the patients were supplemented oxygen by nasal cannula @ 4–6 L/min throughout the procedure. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), SPO2 were recorded at baseline and further during the procedure by multipara monitors. Patients were premedicated with IV ondansetron 4 mg and IV glycopyrrolate 0.2 mg followed by administration of study drugs over 10 min via infusion pump. Patients were induced with ketofol intravenously with 20 ml syringe slowly to achieve Ramsay Sedation Score (RSS) 4. Provision of intubation and ventilation were kept ready to deal with severe respiratory depression if any.

HR, SBP, DBP, MAP, oxygen saturation, and respiratory rate were measured at specific time intervals, i. e., after premedication, after study drug, after induction, after insertion of the endoscope and at every 5 minutes for the first 15 min, then every 10 min till the end of the procedure. Facial pain score (FPS 0-10)[5] and RSS 1-6[5] were observed and recorded every 10 min of interval till the end of the procedure and rescue dose of ketofol was supplemented in aliquots of 1 ml if FPS 5, RSS <3, any movement, coughing, gagging or increase in HR and blood pressure >20% from baseline values were observed. Induction dose of ketofol to achieve RSS 4, the number of supplemented aliquots of ketofol and total dose of ketofol was recorded. Intraoperative complications such as bradycardia, hypotension, hypertension, oxygen desaturation, and apnea if any were noted and managed accordingly. Oxygen desaturation was defined as SpO2 <92% for more than 10s or respiratory rate of 8 or below. Apnea was defined as not having spontaneous respiration for at least 20s; both oxygen desaturation and apnea were managed by supporting airway and/or assisted ventilation. Bradycardia was considered when HR decreased to <60 beats/min and was managed with IV atropine 20 μg/kg. A MAP decrease of >20% of baseline was considered as hypotension and was managed with IV fluids and IV mephenteramine 3–6 mg. Hypertension was considered when MAP increased by >20% of baseline and was managed with IV esmolol 0.5–1 μg/kg and if required NTG infusion (5–25 μg/min) was started. Duration of the procedure, i. e., from the time of insertion of endoscope, till it was removed was also recorded. After the completion of the procedure, the patient's oropharyngeal suction was done and the endoscope was removed. Patients were shifted to the postanesthesia care unit (PACU) when eye-opening on command, adequate oropharyngeal reflexes, stable hemodynamics, SpO2 >95% on room air were observed.

Postprocedure vital parameters, postanesthesia recovery score (PARS, minimal score of 12 with no score <1 in any individual category)[6] and RSS were recorded every 15 min till 1 h in PACU. Patients were closely monitored for adverse effects such as restlessness, nausea, vomiting, shivering, cough, abdominal discomfort, and respiratory depression. Rescue analgesics were given (IV diclofenac 75 mg) if the patient complained of pain after the procedure. In case of any adverse events in the PACU, patients were observed in the hospital ward for at least 12 h. At the end of procedure endoscopist and anesthetist satisfaction was assessed and recorded using Satisfaction Score (4 = excellent, 3 = good, 2 = fair, 1 = bad). Time to full recovery was observed, it was considered as from the removal of endoscope till patients achieved PARS >12.[6]

The patients in whom the procedure was aborted due to difficulty in cannulation of the common bile duct and in whom the procedure was conducted under general anesthesia with endotracheal tube for any reason were withdrawn from the study.

The calculation of the required sample size was based on a pilot observation in our institute which showed a mean difference of 2 ml in the dose of ketofol for induction of deep sedation with a standard deviation (SD) of population 1.5 ml. Using this data at a 5% level of significance and 80% power of the study, a sample size of 48 patients in each group was calculated.

Data were statistically described in terms of mean ± SD, or frequencies (number of cases) and percentages when appropriate. Numerical data between both the groups were analyzed using Student's t-test for independent samples. Categorical data were compared using the Chi-Square test. P < 0.05 was considered statistically significant. All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 16 for Microsoft windows.


  Results Top


A total of 106 patients were screened for eligibility to participate in this study. Six patients did not meet the inclusion criteria and the remaining 100 patients were allocated to one of the two study groups. [Figure 1] shows the detailed consort flow diagram of the patient selection and dropouts.
Figure 1: Consort flow diagram

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There was no statistically significant difference in demographic characteristics such as age, sex, weight, BMI, ASA grading, duration of the procedure, and duration of anesthesia (P > 0.05) [Table 1].
Table 1: Comparison of demographic data between the groups

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The total dose of ketofol used during the procedure was found to be more in Group N (118.55 ± 20.62 mg) as compared to Group D (103.31 ± 31.42 mg) (P < 0.05) [Table 2].
Table 2: Dose of Ketofol (5 mg; 1:1) used throughout the procedure

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The induction dose of ketofol used to achieve RSS >4 was significantly higher in Group N (78.54 ± 9.67 mg) as compared to Group D (62.51 ± 19.40 mg) (P < 0.05). Although doses of ketofol supplemented at the time of insertion of endoscope were comparable between the groups (7.6 ± 3.07 vs. 6.7 ± 2.6 mg; P > 0.05), significantly more number of patients in Group D (n = 19 vs. n = 11, P < 0.05) received supplement for FPS > 5 compared to patients in Group N, where more patients received supplement for RSS < 3 (n = 20 vs. n = 11 P < 0.05). However, no statistically significant difference was found in patients requiring supplemental doses for movement, coughing or gagging, and hemodynamic changes at the insertion of the endoscope (P > 0.05). The dose of ketofol supplemented intraprocedurally was also comparable between the groups (P > 0.05). In Group D, there was a statistically significant decrease in HR, from baseline values after giving the study drug, and thereafter till the post procedure period (P < 0.001). Group N shows statistically significant increase in HR from the baseline after giving the study drug which remained high till the end of the procedure and came back to near baseline values after 15 min postprocedure (P < 0.001). When HR was compared between the groups, it was significantly high in Group N at the time of insertion of the endoscope and at various time intervals as compared to Group D (P < 0.001) [Figure 2].
Figure 2: Graphical representation showing mean heart rate and mean arterial pressure in both the groups

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There was decrease in SBP, DBP, and MAP from the baseline values after insertion of endoscope till the end of the procedure in Group D which was significant statistically (P < 0.05). In Group N highly significant increase in SBP, DBP, MAP was seen at the time of insertion of the endoscope and then reached to near baseline values thereafter and post procedurally (P < 0.09), [Figure 3]. Bradycardia and hypotension were observed in three patients in Group D but the difference was statistically insignificant. Increase in respiratory rate from baseline values was observed in both the groups at the time of endoscope insertion, but it was statistically insignificant. None of the patients had episodes of apnea or oxygen desaturation in both groups.{Figure 3}

Time to achieve postanesthesia recovery score >12 and time to full recovery was earlier in Group N as compared to Group D [Table 3]. The number of patients achieving PARS > 12 at 5 min was significantly more in Group N (94%) than Group D (48%), (P < 0.001).
Table 3: Comparison of recovery characteristics in both the groups

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Endoscopist satisfaction score was comparable between the groups (P > 0.05) while anesthetist satisfaction score was more in Group N (3.59 ± 0.49) as compared to Group D (3.33 ± 0.75) (P < 0.05). Postoperative adverse effects were comparable in both groups (P > 0.05).


  Discussion Top


The result of the current study shows that the total dose of ketofol with an adjuvant Nalbuphine was more due to increased dose requirement during induction while supplemental doses at the time of insertion of endoscope and maintenance of sedation were comparable with nalbuphine and dexmedetomidine. At the time of insertion of endoscope supplement of ketofol was given for FPS > 5 in the dexmedetomidine group, whereas patients who received nalbuphine required it to achieve RSS-4. Supplement for movement, coughing, gagging, and hemodynamic changes was comparable between the groups. Group D patients reported a significant decrease in HR and blood pressure from baseline throughout the procedure with delayed recovery in the postoperative period.

ERCP under deep sedation has evolved as a better choice according to various studies to get a good success rate and maximize patient safety by allowing rapid recovery with no or minimal hemodynamic fluctuations. Combination of ketamine and propofol (ketofol) is a beneficial option as it provides a more stable hemodynamic and respiratory profile while preserving sedative and analgesic efficacy and minimizing their respective adverse effects.[7] The addition of adjuvant can further reduce the drug dose and dose-dependent side effects. This study was aimed to evaluate the efficacy of nalbuphine and dexmedetomidine for ketofol-based deep sedation in ERCP.

The induction dose of ketofol to achieve RSS 4 was found to be significantly higher in Group N as compared to Group D, but the supplemental dose of ketofol intraprocedurally was comparable between the groups. Dexmedetomidine activates presynaptic α2 adrenoreceptors, inhibiting the release of norepinephrine and terminating the propagation of pain receptors; hence, in this study, the combination of dexmedetomidine with ketofol reduced the dose during induction as compared to Group N.

Our study shows that in Group D FPS > 5 was observed only at the time of insertion of endoscope and remained statistically insignificant intra procedurally till the end of the procedure as compared to Group N (P > 0.05). Nalbuphine directly or indirectly has less incidence on gagging, coughing, and limb movements, its analgesic potency being equal to morphine and synergistic action with ketofol provided intense analgesia throughout the procedure leading to FPS <5 in Group N when compared to Group D in our study, hence dose of ketofol supplement at the time of insertion of the endoscope was less in Group N.[8]

In our study, patients in Group D were more sedated when compared to patients in Group N (P < 0.001). In the study by Nallam et al., nalbuphine/dexmedetomidine was compared with nalbuphine/propofol under MAC and it was found that sedation level (RSS > 3) was achieved in significantly higher number of patients in Group D as compared to Group P. Presynaptic activation of α2 adrenoceptors inhibits the release of norepinephrine, terminating the propagation of pain signals producing analgesia, sedation, and anxiolysis.[9] Thus, based on these properties of dexmedetomidine, the patients were more sedated in Group D as compared to Group N, so ketofol dose to achieve RSS 4 was significantly less in Group D.

The results of our study demonstrated a statistically significant decrease in HR from baseline values after giving the study drug and thereafter, while it was significantly high in Group N at various time intervals as compared to Group D (P < 0.001). Our results were in concordance to Kulkarni et al. in which they compared nalbuphine versus dexmedetomidine for LMA insertion after induction with propofol and observed that dexmedetomidine decreased HR by 27% after induction which returned to normal by around 15 min (P < 0.001), while it remained almost stable throughout in Group N.[10]

We also noted decrease in SBP, DBP, and MAP from baseline values after 15 min of insertion of the endoscope in Group D (P < 0.05), while in Group N, increase in SBP, DBP, and MAP was observed from baseline at the time of insertion of endoscope.(P < 0.001) Similar to our study Khandey et al. investigated fentanyl versus nalbuphine for hemodynamic response in general anesthesia and found that SBP, DBP, and MAP significantly increased in nalbuphine group than fentanyl in postintubation period at different time intervals.[8] Hassan A compared dexmedetomidine and ketofol for moderate sedation in ERCP observed that Group D had lower HR and MAP after loading dose (P < 0.05). Their findings suggested that ketofol had clinical advantages over dexmedetomidine as regards controlling hemodynamic variability.[5]

Dexmedetomidine stimulates postsynaptic α2 adrenoreceptors, in the central nervous system and inhibits sympathetic activity, thus decreasing blood pressure and HR. Although both drugs were effective in maintaining hemodynamic stability, dexmedetomidine posses predominant sympatholytic activity thus reducing the sympathetic outflow to keep HR and MAP in the lower range.[11] In our study, although we found increase in SBP, DBP, and MAP in the nalbuphine group, it was within 20% baseline values suggesting nalbuphine had smooth hemodynamic responses. Hypotension was noted in three patients in Group D but they responded well to IV fluid boluses and no pharmacological intervention was required.

The effect of dexmedetomidine on human respiration is less marked than those of opioids, IV, and volatile anesthetic agents, while nalbuphine causes plateau or ceiling effect on respiratory depression and analgesia when the dose >20 mg is used.[12],[13] In the current study, a dose of 0.1 μg/kg was used, so it increased the safety and did not cause respiratory depression. In our study increase in respiratory rate could be due to stimulation caused by endoscope insertion as the patients were on spontaneous ventilation. This shows that both the drugs are safe and do not cause respiratory depression as observed in the case of other opioids.

This study shows that time to full recovery was significantly earlier in Group N than Group D.(P < 0.001). Our findings were in consistent with Fabbri et al. in which they compared ketamine, propofol, and low dose remifentanil (GK) versus propofol and remifentanil (GR) and found that time to reach PAR score of 9 and mean discharge time to the ward was significantly earlier in GK versus in GR (P = 0.0078).[14] In contrast to our study, Mukhopadhyay et al. compared three groups of drugs in patients posted for ERCP. Group 1 received propofol with midazolam, Group 2 cocktail of ketamine, propofol, and midazolam. Group 3 were given cocktail with dexmedetomidine and found that recovery time was faster in Group 2 and 3 as compared to Group 1.[4]

In our study, we found that endoscopist was well satisfied in Group D as compared to Group N but the result was statistically insignificant (P > 0.05). Anesthetists satisfaction score was higher in Group N in comparison to Group D which was statistically significant (P < 0.05).

Major limitations of our study were the lack of bispectral index monitoring to titrate the depth of sedation and EtCO2 monitoring to check the adequacy of respiration under deep sedation. It was a single-center study with a small sample size because of the limited number of ERCP procedures in the endoscopy department. To get more authentic results multicentric studies can be done on the large number of patients by overcoming the limitations of our study.


  Conclusion Top


Dexmedetomidine and nalbuphine are effective for ketofol-based deep sedation in ERCP. Dexmedetomidine reduces the total consumption of ketofol and provides smooth hemodynamics, whereas Nalbuphine provides better analgesia and early recovery with high anesthetist satisfaction.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Thosani N, Banerji S. Deep sedation or general anaesthesia for ERCP? Dig Dis Sci 2013;58:3061-3.  Back to cited text no. 1
    
2.
Raymondos K, Panning B, Bachem I, Manns MP, Piepenbrock S, Meier PN. Evaluation of endoscopic retrograde cholangiopancreatography under conscious sedation and general anesthesia. Endoscopy 2002;34:721-6.  Back to cited text no. 2
    
3.
Chainaki IG, Manolaraki MM, Paspatis GA. Deep sedation for endoscopic retrograde cholangiopacreatography. World J Gastrointest Endosc 2011;3:34-9.  Back to cited text no. 3
    
4.
Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine “augmented” sedato analgesic cocktail: An effective approach for sedation in prolonged endoscopic retrograde cholangio-pancreatography. J Anaesthesiol Clin Pharmacol 2015;31:201-6.  Back to cited text no. 4
[PUBMED]  [Full text]  
5.
Hassan A. Dexmedetomidine versus ketofol for moderate sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) comparative study. Egypt J Anaesth 2015;31:15-21.  Back to cited text no. 5
    
6.
Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth 1995;7:89-91.  Back to cited text no. 6
    
7.
Gallo de Moraes A, Racedo Africano CJ, Hoskote SS, Reddy DR, Tedja R, Thakur L, et al. Ketamine and propofol combination (“ketofol”) for endotracheal intubations in critically ill patients: A case series. Am J Case Rep 2015;16:81-6.  Back to cited text no. 7
    
8.
Khanday SB, Mir AH, Sofi KP, Lone AQ, Shah AN. Evaluation and comparison of fentanyl versus nalbuphine for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation in general anesthesia. Anesth Essays Res 2019;13:111-8.  Back to cited text no. 8
[PUBMED]  [Full text]  
9.
Nallam SR, Chiruvella S, Reddy A. Monitored anaesthesia care – Comparison of nalbuphine/dexmedetomidine versus nalbuphine/propofol for middle ear surgeries: A double-blind randomised trial. Indian J Anaesth 2017;61:61-7.  Back to cited text no. 9
[PUBMED]  [Full text]  
10.
Kulkarni AG, Rani BD, Tarkase AS, Barsagde WS. Comparison between nalbuphine propofol and dexmedetomidine propofol for laryngeal mask airway insertion. Med J DY Patil Univ 2016;9:622-6.  Back to cited text no. 10
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11.
Paris A, Tonner PH. Dexmedetomidine in anaesthesia. Curr Opin Anaesthesiol 2005;18:412-8.  Back to cited text no. 11
    
12.
Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care 2000;4:302-8.  Back to cited text no. 12
    
13.
Salman OH. A controlled, double blind, study of adding Nalbuphine to Propofol for laryngeal mask insertion conditions and hemodynamics in adults. Egypt J Anaesth 2015;31:277-81.  Back to cited text no. 13
    
14.
Fabbri LP, Nucera M, Marsili M, Al Malyan M, Becchi C. Ketamine, propofol and low dose remifentanil versus propofol and remifentanil for ERCP outside the operating room: Is ketamine not only a “rescue drug”? Med Sci Monit 2012;18:R575-80.  Back to cited text no. 14
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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