The clinical trial to compare the effect of fentanyl, remifentanil and alfentanil on hemodynamic parameters and pregnancy outcome in patients undergoing ovarian puncture
The aim of present study is to evaluate effects of fentanyl, alfentanil and remifentanil on hemodynamic parameters, recovery time and pregnancy outcome in patients undergoing anesthesia for transvaginal oocyte retrieval. The inclusion criteria include: age under 40 years and fresh embryo transfer. The exclusion criteria include: azoospermia; follicle stimulating hormone greater than 10; endocrine disorders; poor ovarian response and chronic use of drugs. The present study is a randomized, double blind, uncontrolled clinical trial on infertile patients. All patients will be treated with gonadotropin releasing hormone agonist. Two hundred forty patients will be included in the present study. After final oocyte maturation, ultrasound guided oocyte retrieval will be performed under general anesthesia. Induction of general anesthesia in fentanyl group will be conducted with 1.5 micrograms fentanyl, 40 milligrams lidokain and 2 milligrams propofol. The other two groups alfentanil and remifentanil will be anesthetized with 15 micrograms alfentanil and 1.5 micrograms remifentanil. Other drugs will be the same between groups. Postoperative vital signs, nausea and vomiting, shivering, cough, pain severity measured on a visual analog scale and time of consciousness, will be monitored. Biochemical and clinical pregnancy rate and the number of gestational sac will be reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410258677N4
Registration date:2015-01-21, 1393/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-21, 1393/11/01
Registrant information
Name
Farnoush Farzi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
farnoush_farzi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial to compare the effect of fentanyl, remifentanil and alfentanil on hemodynamic parameters and pregnancy outcome in patients undergoing ovarian puncture
Public title
The effect of type of opioid drugs on hemodynamic parameters and pregnancy outcome in patients undergoing ovarian puncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age under 40 years; Fresh embryo transfer cycles.
Exclusion criteria: Azoospermia; Follicle stimulating hormone level greater than 10; Polycystic ovarian syndrome; Endocrine disorders; Poor responders; Unexplained infertility; Cardiopulmonary disease; Chronic use of drugs; Allergy; Difficult embryo transfers; Bloody catheter.
Age
From 19 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Research Deputy of Guilan University of Medical Sciences, Shahid Beheshti Boulevard
City
Rasht
Postal code
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
1930382808
Health conditions studied
1
Description of health condition studied
In vitro fertilization patients
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
Blood pressure
Timepoint
Every three minutes
Method of measurement
Non-invasive
2
Description
Heart rate
Timepoint
Continuous monitoring
Method of measurement
Electrocardiogram - Pulse oximeter
3
Description
Pregnancy outcome
Timepoint
Two weeks and three months after embryo transfer
Method of measurement
Human chorionic gonadotropin test - Ultrasound
4
Description
Recovery time
Timepoint
Since the arrival of the patient to the recovery room until respond to voice commands
Method of measurement
Postanesthesia discharge scoring system
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, induction of general anesthesia will be performed with administration of 1.5 micrograms fentanyl, 40 milligrams lidokain and 2 milligrams propofol
Category
Treatment - Drugs
2
Description
In the second intervention group, induction of general anesthesia will be performed with administration of 15 micrograms alfentanil, 40 milligrams lidokain and 2 milligrams propofol
Category
Treatment - Drugs
3
Description
In the third intervention group, induction of general anesthesia will be performed with administration of 1.5 micrograms remifentanil, 40 milligrams lidokain and 2 milligrams propofol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Medical Institute
Full name of responsible person
Dr Farnoush Farzi
Street address
Mehr Medical Institute, Ershad Street, Shahid Ansari Boulevard
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Dr Farnoush Farzi
Street address
Mehr Medical Institute, Ershad Street, Shahid Ansari Boulevard
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr Medical Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Al-Zahra Hospital, Guilan University of Medical Sciences