Comparison of Two Different Anesthesia Methods in IVF Procedure

Phase 4CompletedNCT05631925

Acibadem University130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

130

Conditions

Oocyte Retrieval

Interventions

propofol bolusDRUG

Propofol will be added in bolus doses of 0.5mg/kg.

propofol infusionDRUG

Propofol will be administered as 10mg/kg/hour infusion.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Acibadem Kozyatagi Hastanesi

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Propofol

The total amount of Propofol (mg) administered during the procedure

Time frame: up to 1 hour

Secondary Outcomes

Observer's assessment of sedation scale (OSS)

Time to reach 5 on the observer's assessment of sedation scale of the patients

Time frame: up to 1 hour

(Post Anesthetic Discharge Scoring System) PADSS

Time of patients to reach PADSS ≥ 9 (Min:0 and Max: 10) PADSS ≥ 9 is suitable for discharge of the patient

Time frame: up to 6 hour

(Satisfaction of patients) STF 1

Patient satisfaction (The scale is in the range of 1-4. 1: the best)

Time frame: up to 6 hour

(Satisfaction of gynecologist) STF 2

Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)

Time frame: up to 1 hour

Data from ClinicalTrials.gov

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