Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

September 20, 2020 updated by: Paraskevi Matsota, Attikon Hospital

Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Attiki
      • Athens, Attiki, Greece, 12462
        • Attikon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

eligible females scheduled for oocyte retrieval

Description

Inclusion Criteria:

  • female patients between 25 and 45 years old that do not meet any of the exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
sedation for oocyte retrieval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
propofol consumption
Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
difference >30% in propofol consumption
from the beginning to the end of the transvaginal oocyte retrieval procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of oocytes retrieved
Time Frame: up to 3 weeks after starting ovarian stimulation treatment
up to 3 weeks after starting ovarian stimulation treatment
percentage of mature oocytes
Time Frame: up to 3 weeks after starting ovarian stimulation treatment
up to 3 weeks after starting ovarian stimulation treatment
fertilization rate
Time Frame: up to 3 weeks after starting ovarian stimulation treatment
up to 3 weeks after starting ovarian stimulation treatment
embryo quality
Time Frame: up to 4 weeks after starting ovarian stimulation treatment
Embryo quality for endometrial transfer or cryopreservation will be assessed according to morphological criteria based on the overall blastomere number, size, appearance and degree of fragmentation
up to 4 weeks after starting ovarian stimulation treatment
positive pregnancy test
Time Frame: up to 3 weeks after transvaginal oocyte retrieval
up to 3 weeks after transvaginal oocyte retrieval
clinical pregnancy
Time Frame: up to 12 weeks after starting ovarian stimulation treatment
confirmed presence of an intrauterine sac with fetal heart activity through transvaginal ultrasound scan at seven weeks of gestation, following a positive serum β-hCG test
up to 12 weeks after starting ovarian stimulation treatment
Live birth
Time Frame: up to 24 weeks after starting ovarian stimulation treatment
birth of a live fetus after 20 weeks of gestation
up to 24 weeks after starting ovarian stimulation treatment
BIS score
Time Frame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
bispectral index score
assessed every 5 minutes during transvaginal oocyte retrieval procedure
Observer's Assessment of Alertness/Sedation scale - OAA/S scale
Time Frame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
used to assess level of sedation during the procedure (5- Responds readily to name spoken in normal tone, 4-Lethargic response to name spoken in normal tone, 3-Responds only after name is called loudly and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking
assessed every 5 minutes during transvaginal oocyte retrieval procedure
airway obstruction
Time Frame: during the procedure
(yes/no)
during the procedure
need to ventilate by mask
Time Frame: during the procedure
yes/no
during the procedure
presence of muscle rigidity
Time Frame: during the procedure
yes/no
during the procedure
presence of bradycardia (heart rate less than 50 bpm)
Time Frame: during the procedure
during the procedure
hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure
Time Frame: during the procedure
during the procedure
dexmedetomidine consumption
Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
total μg
from the beginning to the end of the transvaginal oocyte retrieval procedure
remifentanil consumption
Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
total μg
from the beginning to the end of the transvaginal oocyte retrieval procedure
vasoactive drug consumption
Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
from the beginning to the end of the transvaginal oocyte retrieval procedure
patient satisfaction score
Time Frame: end of procedure
4 point scale (0-poor, 1-good, 2-very good, 3-excellent)
end of procedure
physician satisfaction score
Time Frame: end of procedure
4 point scale (0-poor, 1-good, 2-very good, 3-excellent)
end of procedure
presence of nausea or vomitus
Time Frame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
0-none, 1-nausea, 2-vomitus<2, 3 vomitus>2
from end of procedure to discharge from hospital, approximately 4 hours after procedure
Post Hospital Discharge Score
Time Frame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
time required by patient to be able to return at home
from end of procedure to discharge from hospital, approximately 4 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2018

Primary Completion (ACTUAL)

November 20, 2019

Study Completion (ACTUAL)

November 20, 2019

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

December 2, 2017

First Posted (ACTUAL)

December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 20, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORDEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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