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Comparative study between nalbuphine and dexmedetomidine for conscious sedation in patients undergoing colonoscopy: randomized comparative trial.
Клиническое исследование IV фазыEquivalence TrialСтатьяНазвание и аннотация: Перевод в очереди
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Abdelrady Marwa M, Yousef Hamdy A, Khalaf Khaled A, Abulfadl Omar A, Hassanien Mostafa H
Аннотация
BACKGROUND: Sedation is increasingly preferred for patients undergoing colonoscopy to improve tolerance and procedural success. This study aimed to compare the sedative and analgesic profiles, as well as hemodynamic responses, of dexmedetomidine and nalbuphine during elective colonoscopies.
METHODS: A total of 66 patients scheduled for colonoscopy were randomly divided into two equal groups: one received an intravenous bolus of dexmedetomidine (1 µg/kg) followed by a continuous infusion (0.5 µg/kg/h), and the other received nalbuphine (0.2 mg/kg IV). The primary endpoint was the assessment of sedation depth, while secondary endpoints included pain perception, cardiovascular stability, recovery measures, satisfaction scores, and the occurrence of adverse effects.
RESULTS: Ramsay Sedation Scores (RSS) significantly differed between groups at 15, 20 min, and at the end of the procedure, with nalbuphine producing higher scores after 10 min. Recovery and discharge times were significantly longer in the nalbuphine group (P < 0.05). Both regimens were well tolerated, with no serious complications reported. Patient and endoscopist satisfaction were higher in the nalbuphine group (P < 0.05).
CONCLUSION: Both dexmedetomidine and nalbuphine provided effective sedation during colonoscopy. Dexmedetomidine favored quicker recovery but was associated with greater bradycardia and hypotension. Nalbuphine, while inducing deeper sedation and superior post-procedural analgesia, was associated with longer recovery times but provided better hemodynamic stability.
TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05689242), date 19/1/2023.
METHODS: A total of 66 patients scheduled for colonoscopy were randomly divided into two equal groups: one received an intravenous bolus of dexmedetomidine (1 µg/kg) followed by a continuous infusion (0.5 µg/kg/h), and the other received nalbuphine (0.2 mg/kg IV). The primary endpoint was the assessment of sedation depth, while secondary endpoints included pain perception, cardiovascular stability, recovery measures, satisfaction scores, and the occurrence of adverse effects.
RESULTS: Ramsay Sedation Scores (RSS) significantly differed between groups at 15, 20 min, and at the end of the procedure, with nalbuphine producing higher scores after 10 min. Recovery and discharge times were significantly longer in the nalbuphine group (P < 0.05). Both regimens were well tolerated, with no serious complications reported. Patient and endoscopist satisfaction were higher in the nalbuphine group (P < 0.05).
CONCLUSION: Both dexmedetomidine and nalbuphine provided effective sedation during colonoscopy. Dexmedetomidine favored quicker recovery but was associated with greater bradycardia and hypotension. Nalbuphine, while inducing deeper sedation and superior post-procedural analgesia, was associated with longer recovery times but provided better hemodynamic stability.
TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05689242), date 19/1/2023.