- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362021
Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval
Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Attiki
-
Athens, Attiki, Greece, 12462
- Attikon University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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