NCT07168135

Brief Summary

This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

August 25, 2025

Last Update Submit

September 4, 2025

Conditions

Procedural SedationColonoscopyCecal Intubation Success RatePropofol Adverse Reaction

Keywords

Cecal intubationPsychomotor recoveryProcedural sedationColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Time to psychomotor recovery after the completion of the colonoscopy

    From enrollment until 24 hours after finishing the colonoscopy

Study Arms (2)

Propofol withdrawal arm

EXPERIMENTAL

This group will undergo withholding of the propofol sedation upon intubating the cecum during the colonoscopy.

Drug: propofol (drug)

Propofol continuation arm

NO INTERVENTION

This group will not undergo propofol sedation stoppage upon intubating the cecum during the colonoscopy, and will continue receiving continuous intravenous propofol until the full withdrawal of the colonoscope.

Interventions

propofol (drug)DRUG

Withholding the continuous propofol intravenous drip upon intubating the cecum during the colonoscopy.

Propofol withdrawal arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years.
  • Scheduled ambulatory elective screening or surveillance colonoscopy under MAC.

You may not qualify if:

  • Medical contraindication to anesthesia (i.e., respiratory/cardiac/neurologic compromise, known allergy or adverse reaction to propofol, midazolam, lidocaine, or opiates, …)
  • History of ischemic or hemorrhagic cerebrovascular accident.
  • Baseline cognitive dysfunction (impaired memory, attention deficit, language disorders, …) - in other words, any dysfunction that prevents the subject from understanding the study protocol and/or completing the requested tests and assessments (e.g., playing the minigames, …)
  • Use of more than one psychoactive drug.
  • History of partial colectomy.
  • Unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The American University of Beirut Medical Center

Beirut, 1107, Lebanon

Location

Related Publications (3)

  • El Mokahal A, Daher HB, Yamout R, Hoshaimi N, Ayoub C, Shaib Y, et al. Randomized controlled trial of procedural sequence for same-day bidirectional endoscopy under monitored anesthesia care (RECoVER Trial). iGIE. 2023;2(3):282-91.

    BACKGROUND

  • Bou Daher H, El Mokahal A, Ibrahim MA, Yamout R, Hochaimi N, Ayoub C, et al. General anesthesia and/or deep hypnotic state in propofol-based conscious sedation for endoscopy. iGIE. 2024;3(2):286-92.

    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: 29306520BACKGROUND

MeSH Terms

Interventions

PropofolPharmaceutical Preparations

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Gastroenterology

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 11, 2025

Study Start

May 19, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)