Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: transvaginal oocyte retrieval


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DEX<br>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<br>* sedation for oocyte retrieval<br>|
| MZM<br>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<br>* sedation for oocyte retrieval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol consumption | 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 |  | up to 3 weeks after starting ovarian stimulation treatment | 
| percentage of mature oocytes |  | up to 3 weeks after starting ovarian stimulation treatment | 
| fertilization rate |  | up to 3 weeks after starting ovarian stimulation treatment | 
| embryo quality | 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 |  | up to 3 weeks after transvaginal oocyte retrieval | 
| clinical pregnancy | 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 | birth of a live fetus after 20 weeks of gestation | up to 24 weeks after starting ovarian stimulation treatment | 
| BIS score | bispectral index score | assessed every 5 minutes during transvaginal oocyte retrieval procedure | 
| Observer's Assessment of Alertness/Sedation scale - OAA/S scale | 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 | (yes/no) | during the procedure | 
| need to ventilate by mask | yes/no | during the procedure | 
| presence of muscle rigidity | yes/no | during the procedure | 
| presence of bradycardia (heart rate less than 50 bpm) |  | during the procedure | 
| hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure |  | during the procedure | 
| dexmedetomidine consumption | total μg | from the beginning to the end of the transvaginal oocyte retrieval procedure | 
| remifentanil consumption | total μg | from the beginning to the end of the transvaginal oocyte retrieval procedure | 
| vasoactive drug consumption |  | from the beginning to the end of the transvaginal oocyte retrieval procedure | 
| patient satisfaction score | 4 point scale (0-poor, 1-good, 2-very good, 3-excellent) | end of procedure | 
| physician satisfaction score | 4 point scale (0-poor, 1-good, 2-very good, 3-excellent) | end of procedure | 
| presence of nausea or vomitus | 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 required by patient to be able to return at home | from end of procedure to discharge from hospital, approximately 4 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transvaginal oocyte retrieval, sedation, dexmedetomidine, fentanyl, remifentanil, midazolam