Evaluation of the effect of propofol on headache attack severity and frequency in patients with migraine
Design
Patients candidate for In Vitro Fertilization surgery and history of migraine will be enrolled into the study after signing the consent form and their severity and frequency of headache will be recorded in a questionnaire. Sample size was 60 persons categorized into 1 group. clinical trial, no randomization, no control group.
Settings and conduct
Patients candidate for In Vitro Fertilization surgery referred to Taleghani Hospital with a history of migraine receive propofol infusion during general anesthesia. In this study no blinding was performed
Participants/Inclusion and exclusion criteria
Inclusion criteria
All the female patient between 25 to 50 years old Candidate for IVF(In Vitro Fertilization) surgery
History of migraine
Exclusion criteria
Allergy to egg
Intervention groups
Intervention group: All patient receive Propofol (B.BRUAN company) infusion 100mcg/kg/min during general anesthesia fo In Vitro Fertilization surgery .
Main outcome variables
The effect of propofol on the severity and frequency of migraine headache attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042569N3
Registration date:2020-02-16, 1398/11/27
Registration timing:registered_while_recruiting
Last update:2020-02-16, 1398/11/27
Update count:0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Nima saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 8939
Email address
nimasaeedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of general anesthesia with Propofol infusion on Headache attack severity and frequency in patients with migraine
Public title
The effect of Propofol on Headache attack severity and frequency in patients with migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All the female patient between 25 to 50 years old Candidate for IVF(In Vitro Fertilization) surgery
History of migraine
Exclusion criteria:
Allergy to egg
Age
From 25 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, Arabi Ave , Daneshjoo Blvd ,Velenjak , Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.SBMU.MSP.REC.1398.111
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache severity in patients with migraine
Timepoint
1 , 3 , 6 month after anesthesia
Method of measurement
Visual Analogue Scale
2
Description
Headache frequency in patients with migraine
Timepoint
1 , 3 , 6 month after anesthesia
Method of measurement
questionnaire(Incidence per month)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patient receive Propofol (B.BRUAN company) infusion 100mcg/kg/min during general anesthesia fo In Vitro Fertilization surgery .