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Completed

NCT Number: NCT07166640

Propofol Dose-Finding for Colonoscope Insertion in Adult Patients

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

About this study

The procedure is performed by an experienced endoscopist. If, during passage of the colonoscope through the rectosigmoid junction, the patient moves, experiences pain, vocalizes, or if the MOAA/S score is ≥3 at the second minute after induction, the insertion is defined as unsuccessful, and an additional rescue dose of 0.25-0.5 mg/kg propofol is titrated intravenously. The initial propofol dose for the next patient is then increased by 0.1 mg/kg.

If there is no movement during passage of the rectosigmoid junction, the patient reports no pain, and the MOAA/S score is ≤2 at the second minute after induction, the insertion is defined as successful, and the initial dose for the next patient is decreased by 0.1 mg/kg.

The conditions for colonoscope insertion are evaluated only at the initial attempt. If, after the start of the procedure, the patient experiences pain, moves, vocalizes, or the MOAA/S score is ≥3, an additional dose of 0.25-0.5 mg/kg propofol is titrated as required.

Throughout the procedure, the target is to maintain a MOAA/S score ≤2, which is systematically assessed at 2-minute intervals. Vital signs, procedure duration, and drug dosages are recorded for all patients.

At the end of the procedure, patients are awakened with verbal and tactile stimuli. After completion of colonoscopy, all patients are transferred to the post-anesthesia care unit for close monitoring until achieving a Modified Aldrete score of 10. Patients with a Modified Aldrete score of 10 are discharged.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. ED50

    Time frame: At 2 minutes after induction (during colonoscope insertion)

    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.

Secondary outcomes

  1. ED95

    Time frame: At 2 minutes after induction (during colonoscope insertion)

    The median effective dose (ED95) 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.

  2. Additional propofol dose

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

    After induction until the end of the colonoscopy procedure

  3. total propofol dose

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

    From induction until the end of the colonoscopy procedure

  4. Presence of pain during propofol injection

    Time frame: Immediately after first propofol administration

    Pain during propofol injection will be assessed as a binary variable (Yes/No), evaluated immediately after the first propofol injection. Presence of pain = Yes, Absence of pain = No.

  5. Heart rate

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

    Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.

  6. mean arterial pressure

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

    Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.

  7. SpO2

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

    oxygen saturation parameter will be recorded at the specified time points to evaluate physiological stability during the procedure.

  8. Procedure interruptions due to airway interventions

    Time frame: Throughout the colonoscopy procedure

    The incidence of airway interventions (chin lift, jaw thrust, mask ventilation) and associated procedural interruptions will be recorded.

  9. Minimum SpO₂ value during the procedure

    Time frame: Throughout the colonoscopy procedure

    The lowest SpO₂ value observed during the procedure will be documented.

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

Estimation of the Median Effective Dose of Propofol for Colonoscope Insertion in Adult Patients: A Prospective Dose-Finding Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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