Comparison of Two Different Anesthesia Methods in IVF Procedure

NCT ID: NCT05631925

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2022-08-17

Brief Summary

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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

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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.

Conditions

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Oocyte Retrieval

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

propofol bolus

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

propofol infusion

Intervention Type DRUG

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

Interventions

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propofol bolus

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

Intervention Type DRUG

propofol infusion

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Sevgi Bilgen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevgi Bilgen

Role: STUDY_CHAIR

Acibadem University, Acibadem Kozyatagi Hastanesi

Locations

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Acibadem Kozyatagi Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bilgen S, Erdogan D, Okten SB. Infusion of propofol with bispectral index monitoring does not reduce the amount of propofol used during transvaginal oocyte retrieval procedure. Sci Rep. 2023 Dec 6;13(1):21561. doi: 10.1038/s41598-023-48611-6.

Reference Type DERIVED
PMID: 38057377 (View on PubMed)

Other Identifiers

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SBilgen

Identifier Type: -

Identifier Source: org_study_id

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