Comparison of Two Different Anesthesia Methods in IVF Procedure

NCT05631925 — Phase 4, Completed, 130 participants, Acibadem University

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

Registry	NCT05631925
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, health services research
Enrollment	130 (Actual)
Sponsor	Acibadem University (Other)
Conditions	Oocyte Retrieval
Interventions	propofol bolus, propofol infusion (Drug)
Dates	start 2022-05-27, primary completion 2022-08-17, completion 2022-08-17, first posted 2022-11-30, last updated 2022-12-07
Locations	1 site in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group bolus	Active comparator	Drug: propofol 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 infusion	Active comparator	Drug: propofol 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.

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

+Outcome measures

Primary outcomes

Propofol [up to 1 hour]: The total amount of Propofol (mg) administered during the procedure

Secondary outcomes

Observer's assessment of sedation scale (OSS) [up to 1 hour]: Time to reach 5 on the observer's assessment of sedation scale of the patients
(Post Anesthetic Discharge Scoring System) PADSS [up to 6 hour]: Time of patients to reach PADSS ≥ 9 (Min:0 and Max: 10) PADSS ≥ 9 is suitable for discharge of the patient
(Satisfaction of patients) STF 1 [up to 6 hour]: Patient satisfaction (The scale is in the range of 1-4. 1: the best)
(Satisfaction of gynecologist) STF 2 [up to 1 hour]: Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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)

Facility	City	Country	Status
Acibadem Kozyatagi Hastanesi	Istanbul	Turkey (Türkiye)

+Publications

Results publication: 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 38057377

+Investigators

Sevgi Bilgen, Study chair, Acibadem University, Acibadem Kozyatagi Hastanesi

My Notes

Public

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