Clinical trial NCT03362021: Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval
Official title: Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infertility
Keywords: transvaginal oocyte retrieval
sedation
dexmedetomidine
fentanyl
remifentanil
midazolam
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: eligible females scheduled for oocyte retrieval

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.

Eligibility 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

Primary outcomes:
measure: propofol consumption
timeFrame: from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary outcomes:
measure: number of oocytes retrieved
timeFrame: up to 3 weeks after starting ovarian stimulation treatment
measure: percentage of mature oocytes
timeFrame: up to 3 weeks after starting ovarian stimulation treatment
measure: fertilization rate
timeFrame: up to 3 weeks after starting ovarian stimulation treatment
measure: embryo quality
timeFrame: up to 4 weeks after starting ovarian stimulation treatment
measure: positive pregnancy test
timeFrame: up to 3 weeks after transvaginal oocyte retrieval
measure: clinical pregnancy
timeFrame: up to 12 weeks after starting ovarian stimulation treatment
measure: Live birth
timeFrame: up to 24 weeks after starting ovarian stimulation treatment
measure: BIS score
timeFrame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
measure: Observer's Assessment of Alertness/Sedation scale - OAA/S scale
timeFrame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
measure: airway obstruction
timeFrame: during the procedure
measure: need to ventilate by mask
timeFrame: during the procedure
measure: presence of muscle rigidity
timeFrame: during the procedure
measure: presence of bradycardia (heart rate less than 50 bpm)
timeFrame: during the procedure
measure: hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure
timeFrame: during the procedure
measure: dexmedetomidine consumption
timeFrame: from the beginning to the end of the transvaginal oocyte retrieval procedure
measure: remifentanil consumption
timeFrame: from the beginning to the end of the transvaginal oocyte retrieval procedure
measure: vasoactive drug consumption
timeFrame: from the beginning to the end of the transvaginal oocyte retrieval procedure
measure: patient satisfaction score
timeFrame: end of procedure
measure: physician satisfaction score
timeFrame: end of procedure
measure: presence of nausea or vomitus
timeFrame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
measure: Post Hospital Discharge Score
timeFrame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon University Hospital
state: Attiki
Study officials:
References: