Deep Sedation Clinical Trial
Official title:
The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial
The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.
Status | Not yet recruiting |
Enrollment | 544 |
Est. completion date | July 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Any patient with a clinical indication for receiving same day bi-directional endoscopies. Exclusion Criteria: - Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery. - Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation. - Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients. - Allergic to emulsions or opioids. - ASA score = III |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ruijin Hospital | Second Affiliated Hospital of Soochow University |
Bugajski M, Wieszczy P, Hoff G, Rupinski M, Regula J, Kaminski MF. Modifiable factors associated with patient-reported pain during and after screening colonoscopy. Gut. 2018 Nov;67(11):1958-1964. doi: 10.1136/gutjnl-2017-313905. Epub 2017 Sep 28. — View Citation
Cairns SR, Scholefield JH, Steele RJ, Dunlop MG, Thomas HJ, Evans GD, Eaden JA, Rutter MD, Atkin WP, Saunders BP, Lucassen A, Jenkins P, Fairclough PD, Woodhouse CR; British Society of Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut. 2010 May;59(5):666-89. doi: 10.1136/gut.2009.179804. Review. — View Citation
Cao Y, Yang J, Li J, Ao X, Zhang KY, Shen XC, Chen DF, Lan CH. Comparison of procedural sequences in same-day painless bidirectional endoscopy: Single-center, prospective, randomized study. Dig Endosc. 2017 May;29(3):330-337. doi: 10.1111/den.12847. Epub 2017 Mar 30. — View Citation
Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28. — View Citation
Grocott HP. Propofol sedation improves efficiency and optimizes patient satisfaction during colonoscopy. CMAJ. 2018 Jun 18;190(24):E751. doi: 10.1503/cmaj.69279. — View Citation
Hammami MB, Reddy KM, Pandit P, Chahla EJ, Koro N, Schuelke MJ, Hachem C. Sequence of same-day upper and lower gastrointestinal endoscopy does not affect total procedure' time or medication use: A randomized trial. JGH Open. 2019 Aug 6;3(6):488-493. doi: 10.1002/jgh3.12203. eCollection 2019 Dec. — View Citation
Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x. — View Citation
Igea F, Casellas JA, González-Huix F, Gómez-Oliva C, Baudet JS, Cacho G, Simón MA, De la Morena E, Lucendo A, Vida F; Spanish Society of Digestive Endoscopy. Sedation for gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):720-31. doi: 10.1055/s-0034-1377561. Epub 2014 Jul 25. — View Citation
Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015. Review. — View Citation
Lucendo AJ, Arias Á, González-Castillo S, Angueira T, Guagnozzi D, Fernández-Fuente M, Serrano-Valverde M, Sánchez-Cazalilla M, Chumillas O, Fernández-Ordóñez M, Tenías JM. Same-day bidirectional endoscopy with nonanesthesiologist administration of propofol: safety and cost-effectiveness compared with separated exams. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):301-8. doi: 10.1097/MEG.0000000000000026. — View Citation
Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. Review. — View Citation
Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23. — View Citation
Wadhwa V, Issa D, Garg S, Lopez R, Sanaka MR, Vargo JJ. Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):194-206. doi: 10.1016/j.cgh.2016.07.013. Epub 2016 Jul 21. Review. — View Citation
Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection Rate | Adenoma detection rate is the proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected. In this study, ADR during the colonoscopy will recorded. | 1 year | |
Primary | Adenoma Detection Rate of the right-sided colon | The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction. | 1 year | |
Primary | The boston bowel preparation scale of the right-sided colon | During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups. | 1 year | |
Secondary | Sedation use | During bidirectional endoscopy, the total doses of propofol and fentanyl will be recorded. | 1 year | |
Secondary | Overall Duration of BDE Examinations | The overall duration of both EGD and colonoscopy examinations will be recorded. | 1 year | |
Secondary | Recovery time | Time between the end of the procedure and patient waken-up will be recorded. | 1 year | |
Secondary | Adverse events | Intraprocedure adverse events will be documented (oxygen saturation <90% for >30 s, systolic blood pressure drop for 30 %, and heart rate <50 or >120 beats/min lasting >30 s). | 1 year | |
Secondary | Overall patient satisfaction | Patient satisfaction will be assessed after the procedures using 10-cm visual analog scale. | 1 year |
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