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NCT Number: NCT05631925

Comparison of Two Different Anesthesia Methods in IVF Procedure

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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Key information

Conditions

Oocyte Retrieval

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Acibadem Kozyatagi Hastanesi

Istanbul, 34742, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years
  • ASA I-II
  • Patients who underwent oocyte retrieval for IVF treatment

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Propofol

    Time frame: up to 1 hour

    The total amount of Propofol (mg) administered during the procedure

Secondary outcomes

  1. Observer's assessment of sedation scale (OSS)

    Time frame: up to 1 hour

    Time to reach 5 on the observer's assessment of sedation scale of the patients

  2. (Post Anesthetic Discharge Scoring System) PADSS

    Time frame: 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

  3. (Satisfaction of patients) STF 1

    Time frame: up to 6 hour

    Patient satisfaction (The scale is in the range of 1-4. 1: the best)

  4. (Satisfaction of gynecologist) STF 2

    Time frame: up to 1 hour

    Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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