Propofol or sodium thiopental in patients undergoing reproductive assisted technologies: comparative efficacy in hemodynamic recovery from anesthesia and outcome of oocyte retrieval
This study aimed at investigating the side effects, hemodynamic effects, and pregnancy outcome of the drugs. During this double blinded randomized controlled trial study, The patients were assigned to two equal groups (each 45) with one receiving Thiopental and the other Propofol as the anesthetic. The Thiopental and Propofol groups were respectively induced with 5mg/kg of Thiopental Sodium and 2.5 mg/kg of Propofol and. The entry Hemodynamic parameters of the patients were documented. During the anesthesia process, Hemodynamic parameters were checked at five-minute intervals. Also, after punctuation at 0-5-10 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303135393N2
Registration date:2013-05-14, 1392/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-14, 1392/02/24
Registrant information
Name
Hamid Reza Soltani.G
Name of organization / entity
Yazd Islamic Azad University, Medical Society of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 1817
Email address
hrsgmed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of medical sciences and health services.
Expected recruitment start date
2012-04-27, 1391/02/08
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Propofol or sodium thiopental in patients undergoing reproductive assisted technologies: comparative efficacy in hemodynamic recovery from anesthesia and outcome of oocyte retrieval
Public title
Effects of Propofol or sodium thiopental on treatment outcomes in patients undergoing reproductive assisted technologies
Purpose
Treatment
Inclusion/Exclusion criteria
(inclusion criteria: lack of infertility problems in the women and the presence of fertility problems in their husbands; Informed consent)
(Exclusion criteria: History of Hypertension; chronic respiratory diseases; thyroid disorders; severe side effects of drugs during the experiment)
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethic committee, reproductive and infertility reseach center, Yazd
Street address
Infertility research center of Shahid Sadoughi University of medical sciences and health services, Yazd, Iran
City
Yazd
Postal code
Approval date
2012-03-07, 1390/12/17
Ethics committee reference number
3763
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
5, 10, 15, 20 minutes after sedation
Method of measurement
mmHg
2
Description
Diastolic blood pressure
Timepoint
before sedation
Method of measurement
mmHg
3
Description
Heart rate
Timepoint
before sedation
Method of measurement
mmHg
4
Description
Respiratory rate
Timepoint
before sedation
Method of measurement
counting
5
Description
Rapid response to vocal stimulant
Timepoint
5, 10, 15 and 20 minutes after anesthesia
Method of measurement
observation
6
Description
Vommiting
Timepoint
After Anesthesia
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
propofol
Category
Treatment - Drugs
2
Description
sodium thiopental
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of infertility, Yazd University of medical sciences and health sciences
Full name of responsible person
Dr Mohammad Dehghan
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of medical sciences
Full name of responsible person
Reza Jooya
Street address
Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of medical sciences
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
Shahid Sadoughi University of medical sciences
Full name of responsible person
Mohammad Dehghan Tezerjani
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
Drdehghan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of medical sciences and health services
Full name of responsible person
Mohammad Hossein Jarahzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
Dr.jarahzadeh@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Branch, Islamic Azad university
Full name of responsible person
Hamid Reza Soltani
Position
General physician
Other areas of specialty/work
Street address
School of medicine, Islamic Azad University, Safaeiyeh
City
Yazd
Postal code
8916783189
Phone
+98 35 1821 0540
Fax
Email
Hrsgmed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)