Comparison of Two Different Anesthesia Methods in IVF Procedure

Phase 4

Completed

• Conditions: Oocyte Retrieval
• Interventions: Drug: propofol bolus; Drug: propofol infusion

• Registration Number: NCT05631925
• Lead Sponsor: Acibadem University

Brief Summary

In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.

Detailed Description

130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.

Study Timeline

• Study Start: 2022-05-27
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-19
• Study First Posted: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-03
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Over 18 years
• ASA I-II
• Patients who underwent oocyte retrieval for IVF treatment

Exclusion Criteria

1. The patient does not want to participate
2. ASA > II patients
3. Patients under 18 years of age
4. Patients who are allergic to the drugs used
5. Patients with mental illness
6. Patients with alcohol or substance addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group bolus	propofol bolus	Propofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient.
Group infusion	propofol infusion	Propofol will be administered as 10mg/kg/hour infusion. The infusion dose will be adjusted so that the Bispectral index (BIS) is in the range of 40-60.

Primary Outcome Measures

Name	Time	Method
Propofol	up to 1 hour	The total amount of Propofol (mg) administered during the procedure

Secondary Outcome Measures

Name	Time	Method
Observer's assessment of sedation scale (OSS)	up to 1 hour	Time to reach 5 on the observer's assessment of sedation scale of the patients
(Satisfaction of patients) STF 1	up to 6 hour	Patient satisfaction (The scale is in the range of 1-4. 1: the best)
(Satisfaction of gynecologist) STF 2	up to 1 hour	Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)
(Post Anesthetic Discharge Scoring System) PADSS	up to 6 hour	Time of patients to reach PADSS ≥ 9 (Min:0 and Max: 10) PADSS ≥ 9 is suitable for discharge of the patient

Trial Locations

Locations (1)

Acibadem Kozyatagi Hastanesi; 🇹🇷 Istanbul, Turkey