Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

NCT06378879 | Not Yet Recruiting

• 1 other identifier: 1073/1/3/26
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

Propofol; Dormicum; Infusion; Bolus; Gastroscopy

Outcome Measures

Primary Outcomes (3)

• 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

• Total dose of propofol (mg)

  Total dose of propofol (mg) used during the upper endoscopy procedure

  30 minutes

• Recovery time (minutes)

  Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation

  30 minutes

Secondary Outcomes (3)

• Involuntary movement

  30 minutes

• Quality of sedation

  30 minutes

• Adverse events

  30 minutes

Study Arms (2)

Continuous infusion (CI group) of propofol

ACTIVE COMPARATOR

CI was defined by continuous propofol infusion at a 3 mg/ kg/h rate with induction using benzodiazepine (2 mg dormicum i.v.) to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.

Drug: Propofol 100 MG in 10 ML Injection

Intermittent bolus injection (BI group) of propofol

ACTIVE COMPARATOR

BI was defined by intermittent use of 20 mg propofol boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.

Drug: Propofol 100 MG in 10 ML Injection

Interventions

Propofol 100 MG in 10 ML Injection DRUG

Sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes), any involuntary patient movement, quality of sedation (VAS) and adverse events

Also known as: Diprivan (100mg/10ml)

Continuous infusion (CI group) of propofol; Intermittent bolus injection (BI group) of propofol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders
• Age between 18 and 85 years old
• Referred to standard upper endoscopy at Luzmila Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Balqa Applied University: lead
• Luzmila Hospital: collaborator

Related Publications (10)

• 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.

  PMID: 24206547 BACKGROUND

• 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.

  PMID: 16573781 BACKGROUND

• 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.

  PMID: 10718389 BACKGROUND

• 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.

  PMID: 16128939 BACKGROUND

• 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.

  PMID: 18440381 BACKGROUND

• 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.

  PMID: 21072716 BACKGROUND

• 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.

  PMID: 29306520 BACKGROUND

• 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.

  PMID: 22631051 BACKGROUND

• 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/

  PMID: 28722969 BACKGROUND

• 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.

  PMID: 36531676 BACKGROUND

Related Links

• University website

MeSH Terms

Interventions

Propofol; Injections

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Tarek Mazzawi, MD, PhD

  Faculty of Medicine, Al-Balqa Applied University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek Mazzawi, MD, PhD

CONTACT

+962795698164; tarek.mazzawi@bau.edu.jo

Fayez Alhadidi, MD

CONTACT

+962795502133

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 23, 2024
• Study Start: September 6, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During 2025
• Access Criteria: According to publishing journal