Clinical trial NCT06378879: Intermittent Boluses Versus Infusion of Propofol During Gastroscopy
Official title: Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: Propofol
Dormicum
Infusion
Bolus
Gastroscopy
Lead sponsor: Al-Balqa Applied University
Sponsor class: OTHER
Collaborators: name: Luzmila Hospital
First posted: 2024-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sedation induction time (minutes)
timeFrame: 30 minutes
measure: Total dose of propofol (mg)
timeFrame: 30 minutes
measure: Recovery time (minutes)
timeFrame: 30 minutes
Secondary outcomes:
measure: Involuntary movement
timeFrame: 30 minutes
measure: Quality of sedation
timeFrame: 30 minutes
measure: Adverse events
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Al-Balqa Applied University
name: Tarek Mazzawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: 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.
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.
citation: Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/
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.