Propofol Dose-Finding for Colonoscope Insertion in Adult Patients

NCT07166640 | Completed

• 1 other identifier: KSH-ANREA-BG-07
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective dose-finding study is to determine the ED50 of propofol required for successful colonoscope insertion in adult patients. The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope passes the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient is increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient is decreased by 0.1 mg/kg. The primary outcome is the determination of the ED50 of propofol for successful colonoscope insertion until passage of the rectosigmoid junction.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (1)

• ED50

  The median effective dose (ED50) of propofol required for successful colonoscope insertion in geriatric patients will be determined using the modified Dixon's up-and-down method. Successful insertion is defined as the absence of movement or vocalization and a MOAA/S score ≤2 within 2 minutes after induction, maintained until the colonoscope passes the rectosigmoid junction.

  At 2 minutes after induction (during colonoscope insertion)

Secondary Outcomes (9)

• ED95

  At 2 minutes after induction (during colonoscope insertion)

• Additional propofol dose

  The cumulative amount of rescue propofol administered during the procedure will be recorded.

• total propofol dose

  The cumulative amount of total propofol administered during the procedure will be recorded.

• Presence of pain during propofol injection

  Immediately after first propofol administration

• Heart rate

  Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).

Study Arms (1)

Group mono-Propofol

OTHER

The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope passes the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient is increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient is decreased by 0.1 mg/kg.

Drug: Propofol

Interventions

Propofol DRUG

The initial dose is 1.5 mg/kg, adjusted in increments or decrements of 0.1 mg/kg according to the modified Dixon's up-and-down method. Additional rescue doses of 0.25-0.5 mg/kg is titrated if insertion is unsuccessful.

Group mono-Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who provided informed consent to participate
• Patients scheduled for colonoscopy
• ASA physical status I-III
• Male and female patients aged 18-65 years

You may not qualify if:

• Patients who did not provide consent
• Known allergy to propofol
• Body weight \<40 kg
• Body mass index (BMI) \>30 kg/m²
• Presence of acute or chronic pain
• Chronic alcohol consumption
• Use of antipsychotic, antidepressant, or hypnotic medications
• Patients with obstructive sleep apnea syndrome (STOP-Bang score ≥3)
• Patients with known anorectal diseases such as hemorrhoids, anal fissure, or anal fistula
• History of oncological disease
• Uncontrolled hypertension (blood pressure \>180/110 mmHg)
• Severe hepatic or renal dysfunction
• Acute respiratory tract infection or other chronic respiratory disorders
• Patients with a history of colorectal surgery

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• Liu FK, Wan L, Shao LJZ, Zou Y, Liu SH, Xue FS. Estimation of effective dose of propofol mono-sedation for successful insertion of upper gastrointestinal endoscope in healthy, non-obese Chinese adults. J Clin Pharm Ther. 2021 Apr;46(2):484-491. doi: 10.1111/jcpt.13312. Epub 2020 Nov 20.

  PMID: 33217028 BACKGROUND

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Bedirhan Günel

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 10, 2025
• Study Start: September 12, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)