Comparison of the effect of midazolam, fentanyl and placebo on hemodynamic changes caused by spinal blocks in pregnant women undergoing cesarean section referred to valiasr hospital
The aim of this study is to compare the effect of midazolam and fentanyl with placebo on hemodynamic changes caused by spinal analgesia in pregnant women undergoing cesarean section referred to Valiasr hospital. It's a triple blind interventional study which pregnant women undergoing cesarean section will be enrolled in. Patients will randomly divide into three groups:
The first group:injection of 1 mg midazolam (diluted in 1 ml)
The second group: injection of 50 micrograms of fentanyl (1 ml)
The third group: injections of placebo (1 ml of distilled water)
Major inclusion criteria: women undergoing cesarean section
Major exclusion criteria: drop in the fetal heart rate; sensitivity to fentanyl and midazolam.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704085225N7
Registration date:2017-05-10, 1396/02/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of midazolam, fentanyl and placebo on hemodynamic changes caused by spinal blocks in pregnant women undergoing cesarean section referred to valiasr hospital
Public title
Comparison of the effect of midazolam, fentanyl and placebo on hemodynamic changes caused by spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Major inclusion criteria: women undergoing cesarean section
Major exclusion criteria: drop in the fetal heart rate; sensitivity to fentanyl and midazolam.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.TUMS.REC.1396.2930
Health conditions studied
1
Description of health condition studied
Cesarean Section
ICD-10 code
082
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Diastolic blood pressure
Timepoint
Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25
Method of measurement
using Sphygmomanometer in mmHg
2
Description
Systolic blood pressure
Timepoint
Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25
Method of measurement
using Sphygmomanometer in mmHg
3
Description
heart beat
Timepoint
Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25
Method of measurement
Based on the number of beats per minute on heart rate monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intravenous injection of 1 mg midazolam (diluted in 1 ml)
Category
Other
2
Description
Intravenous injection of 50 micrograms of fentanyl (1 ml)
Category
Other
3
Description
Intravenous placebo included (1 ml of distilled water)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz blvd. and Qods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Science
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
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)