Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

Anesthesia Clinical Trial

Official title:

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378879
• Other study ID #: 1073/1/3/26
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: Al-Balqa Applied University
• Contact: Tarek Mazzawi, MD, PhD
• Phone: +962795698164
• Email: tarek.mazzawi[@]bau.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.

Description:

Patients of both genders, aged between 18 and 85 years old and referred to standard upper endoscopy at Luzmila Hospital will be included in the study. Patients who are pregnant, have known allergies to the drugs used or a history of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension) or gastrectomy, are American Society of Anesthesiologist (ASA) class ≥ IV (11), or are unable to provide informed consent will be excluded from participating in the study. The patients undergoing a standard upper endoscopy will be randomly assigned to either continuous infusion (CI group) of propofol (Diprivan) with induction using benzodiazepine (2 mg Dormicum i.v.) or only intermittent bolus injection (BI group) of propofol (Diprivan) infused by an anesthesiologist. BI was defined by intermittent use of 20 mg propofol (Diprivan) boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug. CI was defined by continuous propofol (Diprivan) infusion at a 3 mg/ kg/h rate.

The anesthesiologist will follow up the patient during the first observation period, the average time spent in the recovery area and register the requied data during the procedure using Aldrete score (a post anesthesia recovery score where a minimum score of 8 is required for discharge).

The patients' identities will be coded and the data will be kept confidential. The study protocol will be performed according to the Decalrations of Helsinki and will be applied for approval by the Institutional Review Board at Al-Balqa Applied University. Written informed consent was obtained from all patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients of both genders

• Age between 18 and 85 years old

• Referred to standard upper endoscopy at Luzmila Hospital

Exclusion Criteria:

• Patients who are pregnant,

• Known allergies to the used drugs

• History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)

• Previous history of gastrectomy,

• Patients are American Society of Anesthesiologist (ASA) class = IV ,

• Patients are unable to provide informed consent

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol 100 MG in 10 ML Injection
Sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes), any involuntary patient movement, quality of sedation (VAS) and adverse events

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Al-Balqa Applied University	Luzmila Hospital

References & Publications (10)

ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No abstract available. — View Citation

Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x. — View Citation

Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ — View Citation

Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11. — View Citation

Gonzalez-Santiago JM, Martin-Noguerol E, Vinagre-Rodriguez G, Hernandez-Alonso M, Duenas-Sadornil C, Perez-Gallardo B, Mateos-Rodriguez JM, Fernandez-Bermejo M, Robledo-Andres P, Molina-Infante J. Intermittent boluses versus pump continuous infusion for endoscopist-directed propofol administration in colonoscopy. Rev Esp Enferm Dig. 2013 Aug;105(7):378-84. doi: 10.4321/s1130-01082013000700002. — View Citation

Jung M, Hofmann C, Kiesslich R, Brackertz A. Improved sedation in diagnostic and therapeutic ERCP: propofol is an alternative to midazolam. Endoscopy. 2000 Mar;32(3):233-8. doi: 10.1055/s-2000-96. — View Citation

McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046. — View Citation

Riphaus A, Geist C, Schrader K, Martchenko K, Wehrmann T. Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: a prospective randomized trial. Scand J Gastroenterol. 2012 Sep;47(8-9):1078-85. doi: 10.3109/00365521.2012.685758. Epub 2012 May 28. — View Citation

Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63. doi: 10.1111/j.1572-0241.2005.41672.x. — View Citation

Roelandt P, Haesaerts R, Demedts I, Bisschops R. Implementation of the Aldrete score reduces recovery time after non-anesthesiologist-administered procedural sedation in gastrointestinal endoscopy. Endosc Int Open. 2022 Dec 15;10(12):E1544-E1547. doi: 10.1055/a-1964-7458. eCollection 2022 Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation induction time (minutes)	Sedation induction time (minutes) is the time measured from the deep sedation induction until the patient is deeply sedated	30 minutes
Primary	Total dose of propofol (mg)	Total dose of propofol (mg) used during the upper endoscopy procedure	30 minutes
Primary	Recovery time (minutes)	Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation	30 minutes
Secondary	Involuntary movement	Any involuntary patient movement during the endoscopy procedure under deep sedation	30 minutes
Secondary	Quality of sedation	How deeply is the patient sedated (VAS) as assessed by the endoscopist (1 good, 2 moderate, 3 poor)	30 minutes
Secondary	Adverse events	Any adverse events occurring during the procedure such as apnea, dyspnea, hiccups, jerky movements...etc	30 minutes

External Links

•   University website