Cognitive RecoverySEDCOGNCT07267377
Effects of Different Sedation Techniques on Early Cognitive Recovery After Ambulatory Gynecologic Surgery
A study testing Propofol-Fentanyl, Ketamine-Fentanyl and Propofol + Ketamine + Fentanyl (Ketofol) in people with Cognitive Recovery and Sedation, run by Sait Fatih Öner at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical trial aims to compare the effects of three commonly used sedoanalgesia regimens on early cognitive recovery in patients undergoing ambulatory gynecologic surgery (dilatation and curettage). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cognitive Recovery, Sedation, Ambulatory Gynecologic Surgery
- What is being tested?
- Propofol-Fentanyl, Ketamine-Fentanyl and Propofol + Ketamine + Fentanyl (Ketofol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Sep 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-60 years
- ASA physical status I-III
- Scheduled for ambulatory dilation and curettage (D\&C) under sedoanalgesia
- No neurological or psychiatric disorders
Who cannot join
- History of neurological, psychiatric, or cognitive disorders
- Inability to complete or comprehend cognitive assessment tests (MMSE)
- Known drug or alcohol abuse
- Pregnancy
- Severe hepatic or renal dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethi Sekin City Hospital
Elâzığ, Elaziğ, 23050
About this study
Official title: Effects of Sedation Techniques on Early Cognitive Recovery in Ambulatory Gynecologic Surgery: A Prospective Randomized Study
This prospective, randomized, double-blind clinical trial aims to compare the effects of three commonly used sedoanalgesia regimens on early cognitive recovery in patients undergoing ambulatory gynecologic surgery (dilatation and curettage).
The main objective of the study is to determine whether the use of propofol-fentanyl, ketamine-fentanyl, or their combination (ketofol-fentanyl) influences the recovery of cognitive functions during the early postoperative period.
Read more
The primary outcome is the change in the Mini-Mental State Examination (MMSE) score between baseline and recovery.
Secondary outcomes include awakening time, Aldrete recovery score (ARS), pain intensity using the visual analog scale (VAS) at 10 and 30 minutes, hemodynamic parameters, and adverse events.
Participants will be randomly assigned to one of three groups:
Group P: Propofol-fentanyl
Group K: Ketamine-fentanyl
Group KP: Propofol + ketamine + fentanyl
All patients will receive sedation to achieve a Ramsay Sedation Scale score of 3-4. Cognitive function will be assessed preoperatively and after recovery in the post-anesthesia care unit.
The study seeks to determine whether the combined use of ketamine and propofol provides any advantage in cognitive recovery or hemodynamic stability compared to single-agent sedation.
Read the detailed description
Early postoperative cognitive recovery is an important indicator of patient safety and discharge readiness in ambulatory anesthesia. Various sedative-analgesic combinations are used for gynecologic day-case procedures; however, their effects on early cognitive recovery remain unclear.
This prospective, randomized, double-blind clinical trial was conducted to compare the effects of three commonly used sedoanalgesia regimens - propofol-fentanyl, ketamine-fentanyl, and their combination (ketofol-fentanyl) - on postoperative cognitive function recovery after dilation and curettage (D\&C).
A total of 108 ASA physical status I-III patients aged 18-60 years were included and randomly allocated into three groups (n=36 each). Sedation was titrated to maintain a Ramsay Sedation Scale (RSS) score of 3-4. Cognitive function was assessed preoperatively and postoperatively using the Mini-Mental State Examination (MMSE).
The primary outcome was the change in MMSE score between baseline and recovery. Secondary outcomes included awakening time, Aldrete recovery score (ADS), visual analog scale (VAS) pain score at 10 and 30 minutes, hemodynamic stability, and adverse events.
The study aimed to identify the sedative regimen that optimizes cognitive recovery and minimizes side effects in ambulatory gynecologic anesthesia, contributing to safer and faster discharge decisions.
- Being tested
- Propofol-Fentanyl, Ketamine-Fentanyl, Propofol + Ketamine + Fentanyl (Ketofol)
- Keywords
- Propofol, Ketamine, Ketofol, Sedoanalgesia, Cognitive Recovery, Ambulatory Surgery, Gynecologic Surgery, Postoperative Recovery, Mini-Mental State Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol-FentanylDrug
Also called Propofol (Diprivan), Fentanyl (Fentanyl Citrate)
Intravenous administration of propofol 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This regimen represents the standard sedoanalgesia practice for gynecologic day-case procedures and serves as one of the comparison arms in the study.
Ketamine-FentanylDrug
Also called Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)
Intravenous administration of ketamine 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C).
This arm evaluates the effects of ketamine-based sedoanalgesia on cognitive and hemodynamic recovery compared with other regimens.
Propofol + Ketamine + Fentanyl (Ketofol)Drug
Also called Propofol (Diprivan) Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)
Intravenous co-administration of propofol 0.5 mg/kg, ketamine (0.5 mg/kg), and fentanyl (1 µg/kg) for sedation during ambulatory dilation and curettage (D\&C).
This combination (known as "Ketofol") aims to balance the sedative and hemodynamic effects of propofol and ketamine, and is compared with single-agent sedoanalgesia regimens.
| Study group | Role | What they receive |
|---|---|---|
| Propofol-Fentanyl Group | Active comparator | Induction propofol 0.5 mg/kg + fentanyl 1 µg/kg; maintenance propofol 0.25 mg/kg as intermittent boluses to maintain RSS=3 Receives: Drug: Propofol-Fentanyl |
| Ketamine-Fentanyl Group | Active comparator | Induction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses Receives: Drug: Ketamine-Fentanyl |
| Propofol + Ketamine + Fentanyl Group (Ketofol) | Active comparator | Induction ketofol 0.75 mg/kg (1:1 mixture of propofol 10 mg/mL and ketamine 50 mg/mL, freshly prepared in a single syringe) + fentanyl 1 µg/kg; maintenance ketofol 0.25 mg/kg as intermittent boluses Receives: Drug: Propofol + Ketamine + Fentanyl (Ketofol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-Mental State Examination (MMSE) Score
Difference between baseline and postoperative MMSE scores measured before sedation and at recovery in the post-anesthesia care unit (PACU). The MMSE assesses early cognitive recovery after ambulatory gynecologic surgery under sedation.
Measured: Baseline and recovery (within approximately 60 minutes post-sedation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2024
- Primary completion1 Jul 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive RecoveryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model with three groups of participants. Each group receives a different sedoanalgesic regimen: propofol-fentanyl, ketamine-fentanyl, or propofol + ketamine + fentanyl (ketofol). Outcomes related to early cognitive recovery and hemodynamic stability are compared among the groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sait Fatih Öner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sait Fatih Öner, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267377
- Sponsor's protocol ID
- no.258551508; November 5, 2024
- Other IDs
- no.258551508; November 5, 2024
- Acronym
- SEDCOG
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was conducted as a prospective, randomized, double-blind clinical trial at a single center. Individual participant data (IPD) will not be shared because no consent for data sharing beyond the study team was obtained, and there is no approved external repository for data storage
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sedation Techniques on Early Cognitive Recovery in Ambulatory Gynecologic Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07267377
- Acronym / sponsor ID
- SEDCOG / no.258551508; November 5, 2024
- Keywords
- Propofol, Ketamine, Ketofol, Sedoanalgesia, Cognitive Recovery, Ambulatory Surgery, Gynecologic Surgery, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sait Fatih ÖnerUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 5 Dec 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.
This prospective, randomized, double-blind clinical trial aims to compare the effects of three commonly used sedoanalgesia regimens on early cognitive recovery in patients undergoing ambulatory gynecologic surgery (dilatation and curettage).
The main objective of the study is to determine whether the use of propofol-fentanyl, ketamine-fentanyl, or their combination (ketofol-fentanyl) influences the recovery of cognitive functions during the early postoperative period.
The primary outcome is the change in the Mini-Mental State Examination (MMSE) score between baseline and recovery.
Secondary outcomes include awakening time, Aldrete recovery score (ARS), pain intensity using the visual analog scale (VAS) at 10 and 30 minutes, hemodynamic parameters, and adverse events.
Participants will be randomly assigned to one of three groups:
Group P: Propofol-fentanyl
Group K: Ketamine-fentanyl
Group KP: Propofol + ketamine + fentanyl
All patients will receive sedation to achieve a Ramsay Sedation Scale score of 3-4. Cognitive function will be assessed preoperatively and after recovery in the post-anesthesia care unit.
The study seeks to determine whether the combined use of ketamine and propofol provides any advantage in cognitive recovery or hemodynamic stability compared to single-agent sedation.
Detailed description
Early postoperative cognitive recovery is an important indicator of patient safety and discharge readiness in ambulatory anesthesia. Various sedative-analgesic combinations are used for gynecologic day-case procedures; however, their effects on early cognitive recovery remain unclear.
This prospective, randomized, double-blind clinical trial was conducted to compare the effects of three commonly used sedoanalgesia regimens - propofol-fentanyl, ketamine-fentanyl, and their combination (ketofol-fentanyl) - on postoperative cognitive function recovery after dilation and curettage (D\&C).
A total of 108 ASA physical status I-III patients aged 18-60 years were included and randomly allocated into three groups (n=36 each). Sedation was titrated to maintain a Ramsay Sedation Scale (RSS) score of 3-4. Cognitive function was assessed preoperatively and postoperatively using the Mini-Mental State Examination (MMSE).
The primary outcome was the change in MMSE score between baseline and recovery. Secondary outcomes included awakening time, Aldrete recovery score (ADS), visual analog scale (VAS) pain score at 10 and 30 minutes, hemodynamic stability, and adverse events.
The study aimed to identify the sedative regimen that optimizes cognitive recovery and minimizes side effects in ambulatory gynecologic anesthesia, contributing to safer and faster discharge decisions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study uses a parallel assignment model with three groups of participants. Each group receives a different sedoanalgesic regimen: propofol-fentanyl, ketamine-fentanyl, or propofol + ketamine + fentanyl (ketofol). Outcomes related to early cognitive recovery and hemodynamic stability are compared among the groups.
| Arm | Type | Receives |
|---|---|---|
| Propofol-Fentanyl Group | Active comparator | Drug: Propofol-FentanylInduction propofol 0.5 mg/kg + fentanyl 1 µg/kg; maintenance propofol 0.25 mg/kg as intermittent boluses to maintain RSS=3 |
| Ketamine-Fentanyl Group | Active comparator | Drug: Ketamine-FentanylInduction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses |
| Propofol + Ketamine + Fentanyl Group (Ketofol) | Active comparator | Drug: Propofol + Ketamine + Fentanyl (Ketofol)Induction ketofol 0.75 mg/kg (1:1 mixture of propofol 10 mg/mL and ketamine 50 mg/mL, freshly prepared in a single syringe) + fentanyl 1 µg/kg; maintenance ketofol 0.25 mg/kg as intermittent boluses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged 18-60 years
- ASA physical status I-III
- Scheduled for ambulatory dilation and curettage (D\&C) under sedoanalgesia
- No neurological or psychiatric disorders
Key exclusion criteria (5 listed)
- History of neurological, psychiatric, or cognitive disorders
- Inability to complete or comprehend cognitive assessment tests (MMSE)
- Known drug or alcohol abuse
- Pregnancy
- Severe hepatic or renal dysfunction
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-FentanylAlso: Propofol (Diprivan), Fentanyl (Fentanyl Citrate)Intravenous administration of propofol 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C). This regimen represents the standard sedoanalgesia practice for gynecologic day-case procedures and serves as one of the comparison arms in the study. | Drug | Propofol-Fentanyl Group |
| Ketamine-FentanylAlso: Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)Intravenous administration of ketamine 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C). This arm evaluates the effects of ketamine-based sedoanalgesia on cognitive and hemodynamic recovery compared with other regimens. | Drug | Ketamine-Fentanyl Group |
| Propofol + Ketamine + Fentanyl (Ketofol)Also: Propofol (Diprivan) Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)Intravenous co-administration of propofol 0.5 mg/kg, ketamine (0.5 mg/kg), and fentanyl (1 µg/kg) for sedation during ambulatory dilation and curettage (D\&C). This combination (known as "Ketofol") aims to balance the sedative and hemodynamic effects of propofol and ketamine, and is compared with single-agent sedoanalgesia regimens. | Drug | Propofol + Ketamine + Fentanyl Group (Ketofol) |
Primary outcome
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline and recovery (within approximately 60 minutes post-sedation)
Difference between baseline and postoperative MMSE scores measured before sedation and at recovery in the post-anesthesia care unit (PACU). The MMSE assesses early cognitive recovery after ambulatory gynecologic surgery under sedation.
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 16 Dec 2025.
- Individual participant dataSharing planned: No. This study was conducted as a prospective, randomized, double-blind clinical trial at a single center. Individual participant data (IPD) will not be shared because no consent for data sharing beyond the study team was obtained, and there is no approved external repository for data storage
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-Fentanyl, Ketamine-Fentanyl and Propofol + Ketamine + Fentanyl (Ketofol) in people with Cognitive Recovery and Sedation, run by Sait Fatih Öner 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 5 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 16 Dec 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?
Change in Mini-Mental State Examination (MMSE) Score (time frame: Baseline and recovery (within approximately 60 minutes post-sedation)). 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 16 Dec 2025.