A Phase 4 interventional study of propofol bolus and propofol infusion in Oocyte Retrieval, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Acibadem University · Phase 4, Interventional, and Health services research
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.
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.
Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Propofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient.
Drug: propofol bolus
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.
Drug: propofol infusion
Propofol will be added in bolus doses of 0.5mg/kg.
Propofol will be administered as 10mg/kg/hour infusion.
Propofol
The total amount of Propofol (mg) administered during the procedure
Time frame: up to 1 hour
Observer's assessment of sedation scale (OSS)
Time to reach 5 on the observer's assessment of sedation scale of the patients
Time frame: up to 1 hour
(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
Time frame: up to 6 hour
(Satisfaction of patients) STF 1
Patient satisfaction (The scale is in the range of 1-4. 1: the best)
Time frame: up to 6 hour
(Satisfaction of gynecologist) STF 2
Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)
Time frame: up to 1 hour
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Acibadem University