Comparison of Two Different Anesthesia Methods in IVF Procedure

Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization

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.

Study Overview

• Status: Completed
• Conditions: Oocyte Retrieval
• Intervention / Treatment: Drug: propofol bolus; Drug: propofol infusion

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34742
    • Acibadem Kozyatagi Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group bolus; Propofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient.	Drug: propofol bolus; Propofol will be added in bolus doses of 0.5mg/kg.
Active Comparator: Group 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.	Drug: propofol infusion; Propofol will be administered as 10mg/kg/hour infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol	The total amount of Propofol (mg) administered during the procedure	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observer's assessment of sedation scale (OSS)	Time to reach 5 on the observer's assessment of sedation scale of the patients	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	up to 6 hour
(Satisfaction of patients) STF 1	Patient satisfaction (The scale is in the range of 1-4. 1: the best)	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)	up to 1 hour

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Chair: Sevgi Bilgen, Acibadem University, Acibadem Kozyatagi Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 19, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: SBilgen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No