KetamineNCT06412861
Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case
A study testing Ketamine and Fentanyl in people with Ketamine and Sedation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ketamine, Sedation, Gynecologic Disease
- What is being tested?
- Ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 1 Aug 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65,
- American Society of Anesthesiologists (ASA) I-II,
Who cannot join
- Patients with a known allergy to any of the drugs used in the study,
- Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i
- intracranial space-occupying lesions,
- Pregnant women,
- Body mass index (BMI) > 30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Medicine
Samsun
About this study
Official title: Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases
Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases
Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.
Read the detailed description
Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients.
Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure.
Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively).
) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS > 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered.
- Conditions
- Ketamine, Sedation, Gynecologic Disease
- Keywords
- ketamine, sedation, gynecological case
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called GROUP A
0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score > 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.
FentanylDrug
Also called GROUP B
1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.
| Study group | Role | What they receive |
|---|---|---|
| ketamine-propofol | Active comparator | 0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. Receives: Drug: Ketamine |
| fentanyl-propofol | Active comparator | 1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical satisfaction
Surgical satisfaction survey:
Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'."
Measured: Postoperative procedure
Incidence of lower extremity movement during the procedure
The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure
Measured: intraoperative
Secondary outcomes (1)
Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)
he side effects occurring during the intraoperative and postoperative periods include:
Recall events (recall of events during surgery) Apnea (holding breath for >15 seconds) Desaturation (SpO2 < 96%) Jaw thrust maneuver Bradycardia (heart rate < 50 beats/min) Skin rash
Measured: 30th minute postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 Apr 2024
- Primary completion30 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KetamineStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Tamdogan, Ondokuz Mayıs University
- Investigators
- ilke tamdoğan, Study director, ndokuz Mayıs University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412861
- Sponsor's protocol ID
- ilke
- Status last verified
- Jun 2024
- First submitted
- 7 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.
PubMed 9356094Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016.
PubMed 10735789
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases
- ClinicalTrials.gov ID
- NCT06412861
- Acronym / sponsor ID
- ilke
- Conditions
- Ketamine, Sedation, Gynecologic Disease
- Keywords
- ketamine, sedation, gynecological case
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 May 2024 (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.
Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases
Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.
Detailed description
Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients.
Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure.
Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively).
) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS > 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| ketamine-propofol | Active comparator | Drug: Ketamine0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. |
| fentanyl-propofol | Active comparator | Drug: Fentanyl1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18-65,
- American Society of Anesthesiologists (ASA) I-II,
Key exclusion criteria (5 listed)
- Patients with a known allergy to any of the drugs used in the study,
- Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i
- intracranial space-occupying lesions,
- Pregnant women,
- Body mass index (BMI) > 30
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 |
|---|---|---|
| KetamineAlso: GROUP A0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score > 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. | Drug | ketamine-propofol |
| FentanylAlso: GROUP B1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be > 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered. | Drug | fentanyl-propofol |
Primary outcome
Surgical satisfaction
Time frame: Postoperative procedure
Surgical satisfaction survey: Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'."
Incidence of lower extremity movement during the procedure
Time frame: intraoperative
The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure
1 secondary outcome
Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)
Time frame: 30th minute postoperative
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 20 Aug 2024.
- Background: PubMed 9356094Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.
- Background: PubMed 10735789Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016.
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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.
ilke tamdoğan study director
ndokuz Mayıs University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Fentanyl in people with Ketamine and Sedation, run by Ondokuz Mayıs University 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 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 20 Aug 2024. 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?
Surgical satisfaction (time frame: Postoperative procedure). The study lists 2 primary outcomes in all. 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 NCT06412861, which also lists 2 linked publications.
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 20 Aug 2024.