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Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362021
Recruitment Status : Terminated (Primary investigator transferred in another hospital; ongoing pandemic;)
First Posted : December 5, 2017
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Paraskevi Matsota, Attikon Hospital

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.

Condition or disease Intervention/treatment
Infertility Procedure: transvaginal oocyte retrieval

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : November 20, 2019

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.
Procedure: transvaginal oocyte retrieval
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.
Procedure: transvaginal oocyte retrieval
sedation for oocyte retrieval




Primary Outcome Measures :
  1. propofol consumption [ Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure ]
    difference >30% in propofol consumption


Secondary Outcome Measures :
  1. number of oocytes retrieved [ Time Frame: up to 3 weeks after starting ovarian stimulation treatment ]
  2. percentage of mature oocytes [ Time Frame: up to 3 weeks after starting ovarian stimulation treatment ]
  3. fertilization rate [ Time Frame: up to 3 weeks after starting ovarian stimulation treatment ]
  4. 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

  5. positive pregnancy test [ Time Frame: up to 3 weeks after transvaginal oocyte retrieval ]
  6. 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

  7. Live birth [ Time Frame: up to 24 weeks after starting ovarian stimulation treatment ]
    birth of a live fetus after 20 weeks of gestation

  8. BIS score [ Time Frame: assessed every 5 minutes during transvaginal oocyte retrieval procedure ]
    bispectral index score

  9. 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

  10. airway obstruction [ Time Frame: during the procedure ]
    (yes/no)

  11. need to ventilate by mask [ Time Frame: during the procedure ]
    yes/no

  12. presence of muscle rigidity [ Time Frame: during the procedure ]
    yes/no

  13. presence of bradycardia (heart rate less than 50 bpm) [ Time Frame: during the procedure ]
  14. hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure [ Time Frame: during the procedure ]
  15. dexmedetomidine consumption [ Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure ]
    total μg

  16. remifentanil consumption [ Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure ]
    total μg

  17. vasoactive drug consumption [ Time Frame: from the beginning to the end of the transvaginal oocyte retrieval procedure ]
  18. patient satisfaction score [ Time Frame: end of procedure ]
    4 point scale (0-poor, 1-good, 2-very good, 3-excellent)

  19. physician satisfaction score [ Time Frame: end of procedure ]
    4 point scale (0-poor, 1-good, 2-very good, 3-excellent)

  20. 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

  21. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
eligible females scheduled for oocyte retrieval
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362021


Locations
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Greece
Attikon University Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
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Responsible Party: Paraskevi Matsota, Associate Professor of Anesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03362021    
Other Study ID Numbers: TORDEX
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paraskevi Matsota, Attikon Hospital:
transvaginal oocyte retrieval
sedation
dexmedetomidine
fentanyl
remifentanil
midazolam
Additional relevant MeSH terms:
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Infertility