Comparison of Two Different Anesthesia Methods in IVF Procedure

Oocyte Retrieval Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631925
• Other study ID #: SBilgen
• Status: Completed
• Phase: Phase 4
• Start date: May 27, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: December 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oocyte Retrieval

Intervention

Drug:
• propofol bolus
Propofol will be added in bolus doses of 0.5mg/kg.
• propofol infusion
Propofol will be administered as 10mg/kg/hour infusion.

Locations

Country	Name	City	State
Turkey	Acibadem Kozyatagi Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol	The total amount of Propofol (mg) administered during the procedure	up to 1 hour
Secondary	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
Secondary	(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
Secondary	(Satisfaction of patients) STF 1	Patient satisfaction (The scale is in the range of 1-4. 1: the best)	up to 6 hour
Secondary	(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