Clinical trial NCT06412861: Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case
Official title: Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketamine
Sedation
Gynecologic Disease
Keywords: ketamine
sedation
gynecological case
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65,
* American Society of Anesthesiologists (ASA) I-II,

Exclusion Criteria:

* 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

Primary outcomes:
measure: Surgical satisfaction
timeFrame: Postoperative procedure
measure: Incidence of lower extremity movement during the procedure
timeFrame: intraoperative
Secondary outcomes:
measure: Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)
timeFrame: 30th minute postoperative
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
affiliation: ndokuz Mayıs University Faculty of Medicine
name: ilke tamdoğan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Badrinath 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.