Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

NCT ID: NCT03362021

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2019-11-20

Brief Summary

The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.

Detailed Description

Women will be consecutively allocated into one of the following two groups using a 1:1 ratio in order to avoid any potential source of bias.

Group DEX: women will receive dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of procedure. At that time point, both total volume (ml) and dose (γ) of dexmedetomidine administered will be recorded.

Group MZM: women will receive remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min και midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. At that time point, both total volume (ml) and dose (γ) of remifentanil administered will be recorded.

In both groups, in case of non-co-operation of the woman (e.g. kinetic response), propofol will be given as a bolus rescue dose as follows: the 1st rescue dose will be 1mg/kg while all the next doses will be 0.5 mg/kg. At the end of the procedure, the number of rescue doses and the total rescue dose (mg) of propofol given will be recorded.

Intraoperative monitoring will include ECG, noninvasive blood pressure, SpO2, EtCO2 and depth of sedation using BIS values and ΟΑSS scale. Also, adverse effects such as hypotension, bradycardia, nausea & vomiting, rigidity, airway obstruction, and need for bag-mask ventilation will be recorded. The use of vasoactive drugs will also be reported.

At the end of the procedure, the time and quality of recovery will be assessed using ΟΑSS scale (max score=5), while postoperatively the Post Anesthesia Discharge Scoring System, as well as woman's and gynecologist's (physician) overall satisfaction related to the sedation techniques used, will be recorded.

Regarding the IVF outcome, the following parameters will be recorded: number of oocytes retrieved, the percentage of mature oocytes, embryo quality, percentage of positive pregnancy test, percentage of clinical pregnancy, the percentage of live birth.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DEX

Sedation with dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure.

transvaginal oocyte retrieval

Intervention Type: PROCEDURE

sedation for oocyte retrieval

MZM

Sedation with remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min and midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure.

transvaginal oocyte retrieval

Intervention Type: PROCEDURE

sedation for oocyte retrieval

Interventions

transvaginal oocyte retrieval

sedation for oocyte retrieval

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paraskevi Matsota

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Attikon University Hospital

Athens, Attica, Greece

Countries

Greece

Other Identifiers

TORDEX

Identifier Type: -

Identifier Source: org_study_id