Comparison of Two Different Anesthesia Methods in IVF Procedure
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2022
CompletedFirst Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 30, 2022
CompletedDecember 7, 2022
December 1, 2022
3 months
November 2, 2022
December 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Propofol
The total amount of Propofol (mg) administered during the procedure
up to 1 hour
Secondary Outcomes (4)
Observer's assessment of sedation scale (OSS)
up to 1 hour
(Post Anesthetic Discharge Scoring System) PADSS
up to 6 hour
(Satisfaction of patients) STF 1
up to 6 hour
(Satisfaction of gynecologist) STF 2
up to 1 hour
Study Arms (2)
Group bolus
ACTIVE COMPARATORPropofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient.
Group infusion
ACTIVE COMPARATORPropofol 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.
Interventions
Eligibility Criteria
You may qualify if:
- Over 18 years
- ASA I-II
- Patients who underwent oocyte retrieval for IVF treatment
You may not qualify if:
- The patient does not want to participate
- ASA \> II patients
- Patients under 18 years of age
- Patients who are allergic to the drugs used
- Patients with mental illness
- Patients with alcohol or substance addiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acibadem Kozyatagi Hastanesi
Istanbul, 34742, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 38057377DERIVED
Study Officials
- STUDY CHAIR
Sevgi Bilgen
Acibadem University, Acibadem Kozyatagi Hastanesi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 30, 2022
Study Start
May 27, 2022
Primary Completion
August 17, 2022
Study Completion
August 17, 2022
Last Updated
December 7, 2022
Record last verified: 2022-12