Comparison of the effect of fentanyl and remifentanil alone versus the effect of adding propofol to fentanyl and remifentanil on postoperative pain intensity in patients who are candidates for cosmetic abdominal surgery
Comparison of the effect of fentanyl and remifentanil alone versus the effect of adding propofol to fentanyl and remifentanil on postoperative pain intensity in patients who are candidates for cosmetic abdominal surgery
Design
Clinical trial with two intervention groups, with parallel groups, phase 3 on 36 patients.
Settings and conduct
Amir al-Momenin Hospital,
In recovery and at 6, 12, and 24 hours after the operation, the amount and intensity of the pain after the operation is measured and compared by the student based on the VAS pattern, and it is done by the researcher or analyst in the analysis stage. And in those with moderate and severe pain, pethidine is injected in the amount of 10mg to 30mg. Finally, the information is entered into the statistical software spss version 26 and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: electiveness of action; no use of drugs and alcohol; sign the informed consent form to enter the study.
Exclusion criteria: the duration of the operation is more than 4 hours; abnormal intraoperative bleeding.
Intervention groups
After general anesthesia with midazolam, fentanyl, sodium thiopental, and atracurium, during anesthesia and surgery in the first group: 1 cc of fentanyl per hour and 2 mg of remifentanil infusion.
In the second group: 1 cc of fentanyl per hour and remifentanil at the rate of 2 mg are given and the same group receives propofol at the rate of 30 cc per hour.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241027063515N1
Registration date:2024-12-08, 1403/09/18
Registration timing:registered_while_recruiting
Last update:2024-12-08, 1403/09/18
Update count:0
Registration date
2024-12-08, 1403/09/18
Registrant information
Name
Ghazale Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3657 4633
Email address
ailarghasemi98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fentanyl and remifentanil alone versus the effect of adding propofol to fentanyl and remifentanil on postoperative pain intensity in patients who are candidates for cosmetic abdominal surgery
Public title
Comparison of the effect of fentanyl and remifentanil alone versus the effect of adding propofol to fentanyl and remifentanil on postoperative pain intensity in patients who are candidates for cosmetic abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Electiveness of action
No use of drugs and alcohol
Sign the informed consent form to enter the study
Exclusion criteria:
The duration of the operation is more than 4 hours
Abnormal intraoperative bleeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.IAU.TMU.REC.1403.166
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain after surgery
Timepoint
in recovery and at 6, 12 and 24 hours after the operation
Method of measurement
VAS Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group: 1 cc of fentanyl per hour and 2 mg of remifentanil infusion.
Category
Prevention
2
Description
The second group: 1 cc of fentanyl per hour and remifentanil at the rate of 2 mg are given and the same group receives propofol at the rate of 30 cc per hour.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirul Mominin Hospital, Tehran
Full name of responsible person
Ghazaleh Ghasemi
Street address
In front of Sardar Jangal Park, Hospital, Shahid Shirmohammadi St., Naziabad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
ailarghasemi98@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsa Nia
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mparsania@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazaleh Ghasemi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ailarghasemi98@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazaleh Ghasemi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ailarghasemi98@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazaleh Ghasemi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
ailarghasemi98@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD