Effect of DrugNCT07166640
Propofol Dose-Finding for Colonoscope Insertion in Adult Patients
A study testing Propofol in people with Effect of Drug, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who provided informed consent to participate
- Patients scheduled for colonoscopy
- ASA physical status I-III
- Male and female patients aged 18-65 years
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kocaeli City Hospital
Kocaeli, Izmit, 41100
About this study
Official title: Estimation of the Median Effective Dose of Propofol for Colonoscope Insertion in Adult Patients: A Prospective Dose-Finding Study
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.
Read the detailed description
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.
- Conditions
- Effect of Drug
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 minutes after induction (during colonoscope insertion)
Secondary outcomes (9)
ED95
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.
Measured: At 2 minutes after induction (during colonoscope insertion)
Additional propofol dose
After induction until the end of the colonoscopy procedure
Measured: The cumulative amount of rescue propofol administered during the procedure will be recorded.
total propofol dose
From induction until the end of the colonoscopy procedure
Measured: The cumulative amount of total propofol administered during the procedure will be recorded.
Presence of pain during propofol injection
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.
Measured: Immediately after first propofol administration
Heart rate
Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.
Measured: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
mean arterial pressure
Hemodynamic parameters will be recorded at the specified time points to evaluate physiological stability during the procedure.
Measured: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
SpO2
oxygen saturation parameter will be recorded at the specified time points to evaluate physiological stability during the procedure.
Measured: Baseline (before sedation); at colonoscope insertion (start of procedure); 2 minutes after insertion; and at the end of the procedure (completion of colonoscopy).
Procedure interruptions due to airway interventions
The incidence of airway interventions (chin lift, jaw thrust, mask ventilation) and associated procedural interruptions will be recorded.
Measured: Throughout the colonoscopy procedure
Minimum SpO₂ value during the procedure
The lowest SpO₂ value observed during the procedure will be documented.
Measured: Throughout the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start12 Sep 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bedirhan Günel, Kocaeli City Hospital
- Investigators
- Bedirhan Günel, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166640
- Sponsor's protocol ID
- KSH-ANREA-BG-07
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33217028
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Median Effective Dose of Propofol for Colonoscope Insertion in Adult Patients: A Prospective Dose-Finding Study
- ClinicalTrials.gov ID
- NCT07166640
- Acronym / sponsor ID
- KSH-ANREA-BG-07
- Conditions
- Effect of Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group mono-Propofol | Other | Drug: PropofolThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who provided informed consent to participate
- Patients scheduled for colonoscopy
- ASA physical status I-III
- Male and female patients aged 18-65 years
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolThe 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. | Drug | Group mono-Propofol |
Primary outcome
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.
9 secondary outcomes
ED95
Time frame: At 2 minutes after induction (during colonoscope insertion)
Additional propofol dose
Time frame: The cumulative amount of rescue propofol administered during the procedure will be recorded.
total propofol dose
Time frame: The cumulative amount of total propofol administered during the procedure will be recorded.
Presence of pain during propofol injection
Time frame: Immediately after first propofol administration
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).
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).
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).
Procedure interruptions due to airway interventions
Time frame: Throughout the colonoscopy procedure
Minimum SpO₂ value during the procedure
Time frame: Throughout the colonoscopy procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 33217028Liu 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.
- Individual participant dataSharing planned: No
Related trials for Effect of Drug
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bedirhan Günel principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Effect of Drug, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 (time frame: At 2 minutes after induction (during colonoscope insertion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07166640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.