The aim of this study: Comparison of Pethidine, Fentanyl and Sufentanyl on hemodynamic changes in pregnant women candidate for elective cesarean section. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A, B and C groups. Randomization will be performed using random block sizes of 3. The study is single center, double blind and phase 3 trial and patients and physician will be blind about the type of injection drug. Inclusion criteria: Pregnant women candidates for cesarean section. Exclusion criteria: Diabetes; hypertension; thyroid disease; cardiopulmonary disease; beta agonist and beta blocker use; opium addiction; preeclampsia; eclampsia. Sample size: 90 patients will participate in the study with 30 patients in each group. Study groups: Interventions: Pethidine 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. caspian tamin pharmaceutical company, Fentanyl 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. caspian tamin pharmaceutical company, Sufentanyl 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. caspian tamin pharmaceutical company. Primary outcome: Heart rate and blood presure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042333611N1
Registration date:2017-09-02, 1396/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Mahsa Adib
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 17 3329 6736
Email address
m.adib@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pethidine, Fentanyl and Sufentanyl on hemodynamic changes in pregnant women candidate for elective cesarean section
Public title
The effect of Pethidine, Fentanyl and Sufentanyl on hemodynamic changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women candidates for cesarean section. Exclusion criteria: Diabetes; hypertension; thyroid disease; cardiopulmonary disease; beta agonist and beta blocker use; opium addiction; preeclampsia; eclampsia.
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
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
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Approval date
2017-01-12, 1395/10/23
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.16
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Heart rate
Timepoint
Before and during intervention, every 5 minutes up to an hour
Method of measurement
In terms of beats per minute using Monitor
2
Description
Blood pressure
Timepoint
Before and during intervention, every 5 minutes up to an hour
Method of measurement
In terms mercury milimeter using Monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Pethidine 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. The drug is produced by Caspian Tamin pharmaceutical company.
Category
Treatment - Drugs
2
Description
Intervention 2: Fentanyl 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. The drug is produced by Caspian Tamin pharmaceutical company
Category
Treatment - Drugs
3
Description
Intervention 3: Sufentanyl 1.5 microgram/kg IV single dose. Preoperatively and every 30 minutes. The drug is produced by Caspian Tamin pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
Khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
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 and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Mahsa Adib
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
mahsaadib1991@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
dr.yousefkolookhi.anesthezia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)