Megan Allen1,2, Kate Leslie3,4,5,6, Geoffrey Hebbard7,8, Ian Jones9,10, Tejinder Mettho3,4, Paul Maruff11,12. 1. Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia. meganliseallen@gmail.com. 2. Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Australia. meganliseallen@gmail.com. 3. Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia. 4. Anaesthesia, Perioperative and Pain Medicine Unit, University of Melbourne, Melbourne, Australia. 5. Department of Pharmacology, University of Melbourne, Melbourne, Australia. 6. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. 7. Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Australia. 8. Department of Medicine, University of Melbourne, Melbourne, Australia. 9. Colorectal Surgery Unit, Royal Melbourne Hospital, Melbourne, Australia. 10. Department of Surgery, University of Melbourne, Melbourne, Australia. 11. Cogstate Ltd, Melbourne, Australia. 12. Centre for Neuroscience, University of Melbourne, Melbourne, Australia.
Abstract
PURPOSE: This study aimed to determine if the incidence of recall was equivalent between light and deep sedation for colonoscopy. Secondary analysis included complications, patient clinical recovery, and post-procedure cognitive impairment. METHODS:Two hundred patients undergoing elective outpatient colonoscopy were randomized to light (bispectral index [BIS] 70-80) or deep (BIS < 60) sedation with propofol and fentanyl. Recall was assessed by the modified Brice questionnaire, and cognition at baseline and discharge was assessed using a Cogstate test battery. RESULTS: The median (interquartile range [IQR]) BIS values were different in the two groups (69 [65-74] light sedation vs 53 [46-59] deep sedation; P < 0.0001). The incidence of recall was 12% in the light sedation group and 1% in the deep sedation group. The risk difference for recall was 0.11 (90% confidence interval, 0.05 to 0.17) in the intention-to-treat analysis, thus refuting equivalence in recall between light and deep sedation (0.05 significance level; 10% equivalence margin). Overall sedation-related complications were more frequent with deep sedation than with light sedation (66% vs 47%, respectively; P = 0.008). Recovery was more rapid with light sedation than with deep sedation as determined by the mean (SD) time to reach a score of 5 on the Modified Observer's Assessment of Alertness/Sedation Scale [3 (4) min vs 7 (4) min, respectively; P < 0.001] and by the median [IQR] time to readiness for hospital discharge (65 [57-80] min vs 74 [63-86] min, respectively; P = 0.001). The incidence of post-procedural cognitive impairment was similar in those randomized to light (19%) vs deep (16%) sedation (P = 0.554). CONCLUSION: Light sedation was not equivalent to deep sedation for procedural recall, the spectrum of complications, or recovery times. This study provides evidence to inform discussions with patients about sedation for colonoscopy. This trial was registered at the Australian and New Zealand Clinical Trials Registry, number 12611000320954.
RCT Entities:
PURPOSE: This study aimed to determine if the incidence of recall was equivalent between light and deep sedation for colonoscopy. Secondary analysis included complications, patient clinical recovery, and post-procedure cognitive impairment. METHODS: Two hundred patients undergoing elective outpatient colonoscopy were randomized to light (bispectral index [BIS] 70-80) or deep (BIS < 60) sedation with propofol and fentanyl. Recall was assessed by the modified Brice questionnaire, and cognition at baseline and discharge was assessed using a Cogstate test battery. RESULTS: The median (interquartile range [IQR]) BIS values were different in the two groups (69 [65-74] light sedation vs 53 [46-59] deep sedation; P < 0.0001). The incidence of recall was 12% in the light sedation group and 1% in the deep sedation group. The risk difference for recall was 0.11 (90% confidence interval, 0.05 to 0.17) in the intention-to-treat analysis, thus refuting equivalence in recall between light and deep sedation (0.05 significance level; 10% equivalence margin). Overall sedation-related complications were more frequent with deep sedation than with light sedation (66% vs 47%, respectively; P = 0.008). Recovery was more rapid with light sedation than with deep sedation as determined by the mean (SD) time to reach a score of 5 on the Modified Observer's Assessment of Alertness/Sedation Scale [3 (4) min vs 7 (4) min, respectively; P < 0.001] and by the median [IQR] time to readiness for hospital discharge (65 [57-80] min vs 74 [63-86] min, respectively; P = 0.001). The incidence of post-procedural cognitive impairment was similar in those randomized to light (19%) vs deep (16%) sedation (P = 0.554). CONCLUSION: Light sedation was not equivalent to deep sedation for procedural recall, the spectrum of complications, or recovery times. This study provides evidence to inform discussions with patients about sedation for colonoscopy. This trial was registered at the Australian and New Zealand Clinical Trials Registry, number 12611000320954.
Authors: Mathias M Petersen; Linnea Ferm; Jakob Kleif; Thomas B Piper; Eva Rømer; Ib J Christensen; Hans J Nielsen Journal: Cancers (Basel) Date: 2020-09-12 Impact factor: 6.639