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The comparative effect of intravenous midazolam and sufentanyl on shivering in cesarean delivery

Protocol summary

Summary
After getting the approval of the local committee of ethics in Bushehr University of Medical Sciences, 300 patients ASA 1 and 2 age between 15 and 45 years old who are candidates for caesarean section and signed informed consent, were randomly allocated into three groups. One control group and 2 intervention groups. Group 1 received placebo after delivery of fetus, group 2 received midazolam 02% mg/kg after delivery of fetus and group 3 received 0.1 mg/kg sufentanyl. Shivering, hemodynamic change, nausea and vomiting will be recorded and compared among the study groups. The monitoring in the four group were the same (NIBPM, Pulse oximetry, HR in minute 1, 3, 10, 20, 30, 45 and in recovery room. Shivering were classified as CROOSLY described

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407191936N13
Registration date: 2014-08-03, 1393/05/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-03, 1393/05/12
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Busheher University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of intravenous midazolam and sufentanyl on shivering in cesarean delivery
Public title
The comparative effect of intravenous midazolam and sufentanyl on shivering in cesarean delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all women age between 15 and 45 years old who are candidates for caesarean section and signed informed consent are eligible to join the study. Exclusion criteria: any contra indication for R/A and those who are sensitive to midazolam or sufentanyl.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Siraf avenue
City
Busheher
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
B-92-15-14

Health conditions studied

1

Description of health condition studied
Shivering after spinal anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Shivering after cesarian delivery
Timepoint
Minutes 15, 30 and 60
Method of measurement
Observation

Secondary outcomes

1

Description
Patients satisfaction
Timepoint
Before discharge
Method of measurement
Question

Intervention groups

1

Description
In control group patient receive 2 milliliter of sterile water as placebo after delivery of fetus
Category
Treatment - Drugs

2

Description
In intervention group 1 patient receive 0/02 mg per kg Midazolam plus strile water up to two milliliter after delivery of fetus
Category
Treatment - Drugs

3

Description
In intervention group 2 patients receive 0/1 mcg per kg Sufentanyl plus strile water up to two milliliter after delivery of fetus
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadayee Khalig Fars hospital
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Street address
Busheher Borj
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Committee Bushehr University of Medical Sciences
Full name of responsible person
Dr Majid Asadi
Street address
Bushehr University of Medical Science- siraf avenue
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Committee Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assosiated professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Siraf avenue
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
dr.najafianaraki@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associated professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Siraf avenue
City
Bushehr
Postal code
Phone
+98 77 1354 0088
Fax
Email
dr.najafianaraki@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associated professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Siraf avenue
City
Postal code
Phone
+98 77 1354 0088
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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