Clinical trial

Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases

Name

ilke

Description

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.

Trial arms

Trial start

2024-04-20

Estimated PCD

2024-05-30

Trial end

2024-06-01

Status

Recruiting

Treatment

Ketamine

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.

Arms:

ketamine-propofol

Other names:

GROUP A

Fentanyl

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.

Arms:

fentanyl-propofol

Other names:

GROUP B

Size

Primary endpoint

Surgical satisfaction

Postoperative procedure

Incidence of lower extremity movement during the procedure

intraoperative

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

1 drug

3 indications

Organization

Ondokuz Mayıs University

Drug

Indication

Indication

Indication