The aim of this study was to comparison of effect of Apotel And Remiphentanil in pain management after elective cesarean Section .This was double-blind study. Number Seventy patients undergoing elective cesarean section divided randomly into two groups Apotel (A) Remifentanil (R ) (each group equally Weeks 35). Inclusion criteria: gestational age 37-42 weeks; 18 to 35 years; Maternal education at least fifth grade; singleton pregnancy; previous cesarean section. Exclusion criteria: unwillingness to participate; having chronic diseases; cardiac medications; respiratory problems; drug abuse; mental disorders; cancer and infectious diseases; people with chronic pain. we injected 3-5 mg per kg Propofol and 1-2 miligram per Kg Atracurium for patient .After we intubated patient. In Apotel group , we injected one gram Apotel in 200 milliliter of normal saline for 20 minutes for patient , after exit placenta and clamping umbilical cord.In the second group, we injected 0.5 micrograms per Kg per minute Remifentanil for patient, after anesthesia and exit fetus and clamping the umbilical cord to the fetus . We recorded pain in patient score with VAS 4 and 12 hours after surgery and amount of drug after 24 hours of surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100320258N12
Registration date:2016-10-07, 1395/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-07, 1395/07/16
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research Arak University of Medical Sciences
Expected recruitment start date
2016-09-18, 1395/06/28
Expected recruitment end date
2018-01-18, 1396/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect Of Apotel And Remiphentanil in Pain management
after elective Cesarean Section
Public title
Comparison of Effect Of Apotel And Remiphentanil in Pain management
after elective Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 37-42 weeks; 18 to 35 years; Maternal education at least fifth grade; singleton pregnancy; previous cesarean section
Exclusion criteria: unwillingness to participate; having chronic diseases; cardiac medications; respiratory problems, drug abuse; mental disorders; cancer and infectious diseases; people with chronic pain
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics committee Arak University of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
848176941
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.ARAKMU.REC.1395.202
Health conditions studied
1
Description of health condition studied
non-emergency hysterectomy
ICD-10 code
o82
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Pain
Timepoint
4 and 12 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
mount of drugs
Timepoint
24 hours after operation
Method of measurement
geram
Secondary outcomes
empty
Intervention groups
1
Description
In Apotel group , we injected one gram Apotel in 200 milliliter of normal saline for 20 minutes for patient , after exit placenta and clamping umbilical cord.
Category
Treatment - Drugs
2
Description
In the second group, we injected 0.5 micrograms per Kg per minute Remifentanyl for patient, after anesthesia and exit fetus and clamping the umbilical cord to the fetus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Katayon Vakilian
Street address
Emam Khomeini street, Taleghani hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Arak medical science university