Colonoscopy ProceduresNCT07809230
Effects of Low-Dose Ketamine Added to Propofol Sedation During Colonoscopy
A study testing Propofol group and Propofol + Ketamine in people with Colonoscopy Procedures and Sedation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colonoscopy Procedures, Sedation
- What is being tested?
- Propofol group and Propofol + Ketamine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2026to 14 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 scheduled for elective colonoscopy
- ASA physical status I-II
Who cannot join
- ASA physical status ≥ III
- Allergy to propofol or ketamine
- History of psychiatric illness
- Advanced cardiac disease
- Pregnancy
- Chronic use of opioids or sedatives
- Inability to cooperate
- Body Mass Index (BMI) > 35 kg/m^2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
Berat DAĞDELEN, 00905538861406, brtdagdelen@gmail.com
Aslı DÖNMEZ, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: The Effects of Adding Low-Dose Ketamine to Propofol Sedation on Bispectral Index Values, Hemodynamic Stability, and Recovery Time in Patients Undergoing Colonoscopy
"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine.
Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."
- Conditions
- Colonoscopy Procedures, Sedation
- Being tested
- Propofol group, Propofol + Ketamine
- Keywords
- colonoscopy procedures, sedation, propofol, ketamine, bispectral index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupProcedure or surgery
Patients in this group will receive standard propofol sedation titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy
Propofol + KetamineProcedure or surgery
Patients in this group will receive a combination of standard propofol sedation and low-dose ketamine (0.25 mg/kg). Propofol will be titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Patients receiving standard propofol sedation according to routine clinical practice during elective colonoscopy Receives: Procedure: Propofol group |
| Propofol + Ketamine Group | Active comparator | Patients receiving standard propofol sedation combined with low-dose ketamine (0.25 mg/kg) according to routine clinical practice during elective colonoscopy Receives: Procedure: Propofol + Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Evaluation of Mean Arterial Pressure (MAP)
Measured: Baseline, at induction, and every 3 minutes until the end of the procedure
Secondary outcomes (2)
Bispectral Index (BIS) Values
Objective assessment of sedation depth using the BIS monitor
Measured: Intraoperative (Continuous monitoring from baseline to the end of the procedure)
Total Propofol Consumption
Total amount of propofol (in mg) consumed to maintain adequate sedation (Ramsay Score 2-3)
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion14 Jan 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy ProceduresStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berat DAĞDELEN, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809230
- Sponsor's protocol ID
- AEŞH-EK-2026-138
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Adding Low-Dose Ketamine to Propofol Sedation on Bispectral Index Values, Hemodynamic Stability, and Recovery Time in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT07809230
- Acronym / sponsor ID
- AEŞH-EK-2026-138
- Conditions
- Colonoscopy Procedures, Sedation
- Keywords
- colonoscopy procedures, sedation, propofol, ketamine, bispectral index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
"This prospective observational study aims to evaluate the effects of adding low-dose ketamine (0.25 mg/kg) to standard propofol sedation on hemodynamic stability, sedation depth, and recovery times in adult patients undergoing elective colonoscopy. Sedation depth will be objectively monitored using the Bispectral Index (BIS) alongside clinical scoring. The study observes and compares two standard sedation regimens routinely used in the clinic: propofol alone versus a combination of propofol and low-dose ketamine.
Researchers will record intraoperative hemodynamic parameters (mean arterial pressure, heart rate, oxygen saturation) and BIS values at regular intervals from baseline to the end of the procedure. Furthermore, postoperative recovery quality, cognitive function, and discharge readiness will be comprehensively assessed using the Modified Aldrete Score, Post Anesthetic Discharge Scoring System (PADSS), and a computerized Psychomotor Vigilance Test (PVT-B) at specific time points. The total amount of propofol consumed to maintain adequate sedation will also be compared between the two observational cohorts."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Procedure: Propofol groupPatients receiving standard propofol sedation according to routine clinical practice during elective colonoscopy |
| Propofol + Ketamine Group | Active comparator | Procedure: Propofol + KetaminePatients receiving standard propofol sedation combined with low-dose ketamine (0.25 mg/kg) according to routine clinical practice during elective colonoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective colonoscopy
- ASA physical status I-II
Key exclusion criteria (8 listed)
- ASA physical status ≥ III
- Allergy to propofol or ketamine
- History of psychiatric illness
- Advanced cardiac disease
- Pregnancy
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 |
|---|---|---|
| Propofol groupPatients in this group will receive standard propofol sedation titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy | Procedure or surgery | Propofol Group |
| Propofol + KetaminePatients in this group will receive a combination of standard propofol sedation and low-dose ketamine (0.25 mg/kg). Propofol will be titrated to achieve a Bispectral Index (BIS) of 60-80 and a Ramsay Sedation Score of 2-3 during elective colonoscopy | Procedure or surgery | Propofol + Ketamine Group |
Primary outcome
Mean Arterial Pressure
Time frame: Baseline, at induction, and every 3 minutes until the end of the procedure
Evaluation of Mean Arterial Pressure (MAP)
2 secondary outcomes
Bispectral Index (BIS) Values
Time frame: Intraoperative (Continuous monitoring from baseline to the end of the procedure)
Total Propofol Consumption
Time frame: At the end of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
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 group and Propofol + Ketamine in people with Colonoscopy Procedures and Sedation, run by Ankara Etlik 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berat DAĞDELEN (00905538861406, brtdagdelen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: Baseline, at induction, and every 3 minutes until the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.