Comparison between the influence of intraoperative Remifentanil and Fentanyl on postoperative pain following adult orthotopic liver transplant surgery: A randomized clinical trial
Comparison between the influence of intraoperative Remifentanil and Fentanyl on postoperative pain following adult orthotopic liver transplant surgery
Design
Two arm parallel group of 64 patients, randomized clinical trial, double blinded, randomization performed by random-numbers table.
Settings and conduct
The patients will be grouped by numeric coding. The patient will not be aware of the type of administered drug. The chief researcher who is responsible for patient's safety and preparing the drugs will be aware of the drug administered. But the resident and the nurse in the operating room will not know which drug is given to the patient. The researcher (responsible anesthesiologist) will prepare two syringes with the same volume and the same appearance (clear fluid in 50 cc- syringe) and these syringes will be given to the nurse/resident in the operating room. The duration of infusion will be the same for both groups. Groups coding is numerical and the intensive care unit personnel and the epidemiologist responsible for analysis of the data
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 65 years old; candidate for orthotopic liver transplant surgery in Taleghani Hospital; no previous history of opioids abuse
Exclusion criteria: Lack of consent from the patient for study enrollment
Intervention groups
Fentanyl group: prescribed Fentanyl infusion during surgery
Remifentanyl group: prescribed Remifentanyl infusion during surgery
Main outcome variables
Amount of postoperative analgesic medications during the first 72 hours after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151012024493N6
Registration date:2023-02-24, 1401/12/05
Registration timing:registered_while_recruiting
Last update:2023-02-24, 1401/12/05
Update count:0
Registration date
2023-02-24, 1401/12/05
Registrant information
Name
Parissa Sezari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 219 4036
Email address
psezari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the influence of intraoperative Remifentanil and Fentanyl on postoperative pain following adult orthotopic liver transplant surgery: A randomized clinical trial
Public title
comparing fentanyl and remifentanil in liver transplant surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years old
Candidate for orthotopic liver transplant surgery in Taleghani Hospital
No previous history of opioids abuse
Exclusion criteria:
Lack of consent from the patient for study enrollment
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Random-number table In this study, people enter the study groups by lottery; In such a way that the type of injectable drug used is placed in the desired number in the sealed opaque envelopes that are coded. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes out one of the pieces of paper from the box. The envelope has the same number as the number inside the selected paper. which is applied to the patient. This work continues until the end of the papers so that the number of patients reaches the desired number in the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients will be grouped by numeric coding. The patient will not be aware of the type of administered drug. The chief researcher who is responsible for patient's safety and preparing the drugs will be aware of the drug administered. But the resident and the nurse in the operating room will not know which drug is given to the patient. The researcher (responsible anesthesiologist) will prepare two syringes with the same volume and the same appearance (clear fluid in 50 cc- syringe) and these syringes will be given to the nurse/resident in the operating room. The duration of infusion will be the same for both groups. Groups coding is numerical and the intensive care unit personnel and the epidemiologist responsible for analysis of the data will not be aware of coding type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medical Scienes
Street address
Shahid Beheshti University of Medical Sciences, Koudakyar st., Daneshgah Sq., Velenjak, Tehran, Iran
City
تهران
Province
Tehran
Postal code
1985717443
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.SBMU.MSP.REC.1401.477
Health conditions studied
1
Description of health condition studied
Liver Transplantation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
َAmount of postoperative analgesic medications
Timepoint
72 hours after surgery
Method of measurement
Calculating the total dose of given analgesics by nursing chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In Fentanyl group, Fentanyl is infused by the rate of 0.03-1 mcgr/Kg body weight/min during surgery.
Category
Treatment - Drugs
2
Description
Intervention group: In Remifentanyl group, Fentanyl is infused by the rate of 0.03-1 mcgr/Kg body weight/min during surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Soodeh Tabashi
Street address
Shahid A'rabi St., Yaman St. , Shahid Chamran Highway