|Year : 2018 | Volume
| Issue : 3 | Page : 437-441
Propofol–midazolam versus propofol–dexmedetomidine as a deep sedation for endoscopic retrograde cholangio-pancreaticoduodenoscopy
Doaa G Diab, Emad El Hefnawy
Department of Anesthesia and Intensive Care, College of Medicine, Mansoura University, Mansoura, Egypt
|Date of Submission||10-Jul-2018|
|Date of Acceptance||08-Oct-2018|
|Date of Web Publication||07-Jan-2019|
Dr. Doaa G Diab
Department of Anesthesia and Intensive Care, College of Medicine, Mansoura University, Mansoura, 35516
Source of Support: None, Conflict of Interest: None
Background Endoscopic retrograde cholangio-pancreaticoduodenoscopy (ERCP) is a day procedure for diagnostic or therapeutic biliary problems. Many kinds of sedation are used to provide patients comfort and facilitate work. Propofol and midazolam is the preferred cocktail. Dexmedetomidine with sedo-analgesic properties makes it another suitable regimen. The aim of this study was to compare the efficacy of adding either midazolam or dexmedetomidine to propofol for procedural sedation during ERCP.
Patients and methods This study was conducted in Mansoura University Hospitals, Gastroenterology Center. A total of 84 patients (40–80 years), American Society of Anesthesiologist II, III, and IV scheduled for ERCP were randomly allocated into two groups: the PM group received propofol–midazolam and the group PD received propofol–dexmedetomidine. Heart rate, mean arterial blood pressure, and SpO2 were recorded at basal, intraoperative, postanesthesia care unit (PACU), till discharge. O2 desaturation, total dose of propofol, intraoperative complications, patients, and surgeon satisfaction were recorded.
Results Heart rate and mean arterial blood pressure showed a significant reduction in group D compared with group M. Onset of deep sedation shows a significant reduction in group D versus group M. Recovery time and onset of discharge from the postanesthesia care unit shows statistically significant prolongation in group D versus group M. The total dose of propofol, intraoperative complications and also surgeon and patient satisfaction were comparable.
Conclusion Administration of 1-μg/kg loading dose of dexmedetomidine or midazolam 1 mg intravenous, followed by intravenous propofol (1 mg/kg) and then 10 mg increments can produce an effective and smooth sedation without causing hemodynamic or respiratory side effects. So, dexmedetomidine could be an important alternative to midazolam for sedation in ERCP and other short procedures.
Keywords: dexmedetomidine, endoscopic retrograde cholangio-pancreaticoduodenoscopy, midazolam, propofol, sedation
|How to cite this article:|
Diab DG, El Hefnawy E. Propofol–midazolam versus propofol–dexmedetomidine as a deep sedation for endoscopic retrograde cholangio-pancreaticoduodenoscopy. Benha Med J 2018;35:437-41
|How to cite this URL:|
Diab DG, El Hefnawy E. Propofol–midazolam versus propofol–dexmedetomidine as a deep sedation for endoscopic retrograde cholangio-pancreaticoduodenoscopy. Benha Med J [serial online] 2018 [cited 2019 Dec 15];35:437-41. Available from: http://www.bmfj.eg.net/text.asp?2018/35/3/437/249414
| Introduction|| |
One-day surgical procedures usually need sedation or sometimes general anesthesia (GA); however GA in these procedures is considered costly and requires to spend more time although it increases the surgical success and alleviate many problems . Endoscopic retrograde cholangio-pancreaticoduodenoscopy (ERCP) is a day procedure commonly used nowadays for many biliary problems either diagnostic or therapeutic .
Many sedation regimens are used for ERCP providing patients more comfort and making the work of the surgeon easier. Propofol and midazolam are considered popular and the preferred cocktail used for day surgeries in general and ERCP in particular, as it provides rapid onset short duration, cardioprotection and early recovery .
Dexmedetomidine, the new-age alpha-2 agonist, having sedo-analgesic properties is another suitable regimen for these procedures preserving the cardiopulmonary function and safety .
This study was conducted aiming to compare the efficacy of adding either midazolam or dexmedetomidine to propofol for procedural sedation during ERCP.
The outcomes of this work was primarily, the onset of deep sedation assessed by the Richmond Agitation Sedation Scale (RASS) , while secondary outcomes included hemodynamics [heart rate (HR), mean arterial blood pressure (MAP)], intraoperative complications (e.g. irritability gagging, etc.), patients and surgeon satisfaction by visual analog score (VAS) , and onset of discharge from the postanesthesia care unit (PACU) by modified Aldrete score .
| Patients and methods|| |
The study was approved by the Mansoura Institutional Review Board (code number: R/16.04.20), and an informed written consent was taken from all patients; this prospective, double-blinded, randomized study was carried out in the Mansoura University Hospitals, Gastroenterology Center from April 2016 to April 2017, 84 patients in the age 40–80 years, American Society of Anesthesiologist II, III, IV, and who were scheduled for ERCP were included in this study. Patients, with severe obstructive or restrictive respiratory disease, decompensated heart, liver, renal diseases, diabetes mellitus, patients with deafness or communicating problems were excluded from this study.
The sample study is calculated according to the previous study results, where the mean±SD of onset of deep sedation assessed by RASS in the propofol–midazolam group is 1.13±0.52 min by two–tail test and α error 0.05 and β error 0.2 (power, 0.8). Thirty-eight cases needed in each group to detect 30% reduction in the onset time and 10% dropout is allowing, so 42 cases needed in each group.
The patients were randomly allocated into two equal groups by closed envelope methods. In group PM, 42 patients received propofol–midazolam and in group PD, 42 patients received propofol–dexmedetomidine.
All patients were investigated routinely for complete blood count, serum creatinine, liver function tests, random blood sugar, and ECG.
Upon arrival in the preoperative room the patients had two intravenous lines inserted; warm intravenous fluids (ringer acetate) were started at 10 ml/kg/h; atropine 0.02 mg/kg and ondansetron 4 mg were administered intravenously. After recording basal vital signs, the patients were transferred to the operative room.
The patients received oxygenation with anO2 mask 5 l/min in the beginning and then oxygenation was continued via a nasal cannula throughout the procedure.
Sedation was induced by midazolam 1 mg intravenous in the PM group, or dexmedetomidine 1 μg/kg intravenous over 10 min in the PD group. Patients in group PM received normal saline in a syringe pump over 10 min to achieve blindness, followed by propofol (1 mg/kg) intravenous, followed by 10 mg increments till deep sedation was achieved by RASS till a 4–5 score is attained in both groups.
HR, noninvasive MAP, and SpO2 were recorded before sedation (basal), then every 10 min till the end of surgery and after recovery, upon arrival to the recovery room, after 15, 30 min and upon discharge. Episodes of oxygen desaturation (<90%) were recorded and managed by increasing the O2 flow, up to intubation if needed. The total dose of propofol and VAS (0–100) was recorded for patient and surgeon satisfaction.
Anesthesiologists who managed the patients were not involved in the outcome measures assessment. An independent investigator who was blinded to patient allocation and not involved in patient management takes the responsibility of the computerized data collection.
Data were assessed for normality by the Shapiro–Wilk W tests by using the statistical package for the social sciences software for Windows, version18 (SPSS Inc., Chicago, Illinois, USA). Data were expressed as number and percentage, median and range, mean and SD. Independent sample t test was used to compare continuous variables exhibiting normal distribution, and χ2 or Fisher’s exact test for noncontinuous variables. Nonparametric data was tested with Mann–Whitney U test. P value less than 0.05 is considered significant.
| Results|| |
There were no statistically significant differences in the demographic data between the two groups as regards age, sex, weight, height, American Society of Anesthesiologist state, duration of ERCP (min) as shown in [Table 1]. The HRs and blood pressure of the two groups as shown in [Table 2] were significantly different (P<0.05) by a reduction in group D compared with group M. Procedural characters in [Table 3]: onset of deep sedation (min) shows a statistically significant reduction in group D compared with group M. The total dose of propofol (mg) shows no statistically significant differences in both groups while the recovery time (min) and onset of discharge from the postanesthesia care unit (min) showed a statistically significant prolongation in group D compared with group M.
|Table 1 Demographic data of the studied groups (age, weight, height, sex, American Society of Anesthesiologist, duration of endoscopic retrograde cholangio-pancreaticoduodenoscopy)|
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|Table 2 Hemodynamics: mean arterial pressure (mmHg) and heart rate (bpm) of the studied groups|
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|Table 3 Procedural characters: onset of deep sedation (min), recovery time (min), total dose of propofol (mg), and onset of discharge from postanesthesia care unit (min)|
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Intraoperative complications: (number of patients suffering from gagging and irritation, vomiting, and O2 desaturation) shows no statistically significant differences in both groups ([Table 4]). Surgeon and patient satisfaction when they were compared by the VAS is shown in [Table 5]; Group D and group M were comparable.
|Table 4 Intraoperative complications: no. of patients suffering from (gagging and irritation, vomiting, and O2 desaturation)|
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| Discussion|| |
Conscious sedation was the mainstay for the endoscopy procedures over the initial decades and lasts for long times. However, over recent years anesthesia services have increasingly been utilized in this field to provide deeper levels of sedation for maximum patient comfort and safety .
ERCP is considered a complex, therapeutic, and diagnostic endoscopic procedure requiring a maximum degree of patient cooperation as any patient movement could affect the procedural success . A previous study proved that the failure rate in ERCP managed with sedation was double that of GA (14 vs. 7%) due to inadequate sedation. Therefore, deep sedation is preferable .
Improving patient satisfaction, comfort, and safety with increasing the efficiency of endoscopy require agents such as propofol, which allow rapid smooth induction of deep sedation and also rapid smooth recovery . Sedation was considered successful if an anesthesiologist does not do considerable intervention .
Muller et al.  discussed the hypothesis that dexmedetomidine is as effective as propofol when combined with fentanyl for effective sedation to be used for ERCP, where the 26 adults patients were randomized to receive either dexmedetomidine or propofol combined with fentanyl. And they concluded that dexmedetomidine alone was not as effective as propofol/fentanyl in providing sedation during an ERCP and required additional analgesic.
Also Mazanikov et al.  concluded that in spite of recommended dexmedetomidine use for procedural sedation it has been reported effective for alcohol withdrawal. When it was examined for suitability of sedation for alcoholics during ERCP, dexmedetomidine alone was insufficient in all patients. Also, the incidence of sedation side effects and undesirable events did not differ between the groups; in addition the Dex group was associated with delayed recovery which is matched with our results.
Muller et al.  also proved that dexmedetomidine was associated with greater hemodynamic instability in the form of reduction in MAP, a lower HR, greater sedation, and a prolonged recovery after the procedure which is matched with our results and was augmented by combination with propofol.
Generally, midazolam was used for providing conscious sedation during ERCP. Recently, dexmedetomidine has been tried, but still lacking more evidence to support its use. However, Sethi et al.  have concluded in their study that dexmedetomidine could be a superior alternative to midazolam for sedation in ERCP.
Many studies have used different doses of midazolam for conscious sedation. For example Habib et al.  examined the effect of a single dose of midazolam (0.015 mg/kg intravenous). In our research work, we used a single dose of 1 mg midazolam intravenous just prior to starting the procedures of ERCP.Studies have used different doses of dexmedetomidine sedation for interventions under local and regional anesthesia, like Arain and Ebert  who used dexmedetomidine in a 1 μg/kg. In cases of carotid endarterectomy under regional anesthesia, McCutcheon et al.  began with dexmedetomidine at 0.5 μg/kg for 5 min and continued with 0.2 μg/kg/h. In contrast, Ibacache et al.  demonstrated a single dose of 0.3 μ/kg intravenous dexmedetomidine for 10 min to achieve sedation and overcome agitation in children who were scheduled for sevoflurane GA for short procedures. In our study, dexmedetomidine was used at a dose of 1 μg/kg loading dose for 10 min just prior to the ERCP. Using these dose regimens help to maintain adequate rapid sedation without imbalance on hemodynamics, respiratory parameters or affecting the quality or rapidity of the recovery scores.
| Conclusion|| |
In conclusion, administration of 1 μg/kg loading dose of dexmedetomidine or midazolam 1 mg intravenous followed by intravenous propofol (1 mg/kg) which is followed by 10 mg increments till deep sedation was achieved by RASS till 4–5 score in both groups, providing effective rapid sedation without hemodynamic or respiratory parameter imbalance. So, dexmedetomidine could be an important alternative to midazolam in ERCP for proper effective sedation and hence it is recommended for other short-duration invasive procedures.
Collaboration between endoscopists and anesthesiologists gives the chance to develop standardized protocols to achieve optimal sedation strategies for ERCP according to the complexity of the procedure and patient characteristics to reach the perfect balance between patient comfort, safety, and efficiency of the ERCP procedures.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]