Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03362021
• Other study ID #: TORDEX
• Status: Terminated
• Start date: January 5, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: September 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• transvaginal oocyte retrieval
sedation for oocyte retrieval

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	propofol consumption	difference >30% in propofol consumption	from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary	number of oocytes retrieved		up to 3 weeks after starting ovarian stimulation treatment
Secondary	percentage of mature oocytes		up to 3 weeks after starting ovarian stimulation treatment
Secondary	fertilization rate		up to 3 weeks after starting ovarian stimulation treatment
Secondary	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
Secondary	positive pregnancy test		up to 3 weeks after transvaginal oocyte retrieval
Secondary	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 ß-hCG test	up to 12 weeks after starting ovarian stimulation treatment
Secondary	Live birth	birth of a live fetus after 20 weeks of gestation	up to 24 weeks after starting ovarian stimulation treatment
Secondary	BIS score	bispectral index score	assessed every 5 minutes during transvaginal oocyte retrieval procedure
Secondary	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
Secondary	airway obstruction	(yes/no)	during the procedure
Secondary	need to ventilate by mask	yes/no	during the procedure
Secondary	presence of muscle rigidity	yes/no	during the procedure
Secondary	presence of bradycardia (heart rate less than 50 bpm)		during the procedure
Secondary	hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure		during the procedure
Secondary	dexmedetomidine consumption	total µg	from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary	remifentanil consumption	total µg	from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary	vasoactive drug consumption		from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary	patient satisfaction score	4 point scale (0-poor, 1-good, 2-very good, 3-excellent)	end of procedure
Secondary	physician satisfaction score	4 point scale (0-poor, 1-good, 2-very good, 3-excellent)	end of procedure
Secondary	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
Secondary	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