The main purpose of this study was to control the pain of patients undergoing bariatric surgery during and after surgery by using less narcotics and thus preventing further complications.
Design
In this study, 50 patients aged 18-80 years who undergo bariatric surgery with inclusion criteria and not having exclusion criteria will be included.Patients will be randomly divided into two groups receiving labetalol or remifentanil, and each participant will be assigned a code.
Settings and conduct
After sample selection, an equal number of patients are randomly assigned to the two groups of remifentanil and labetalol.Postoperative pain at the time of entry into recovery,2,4,6 and 12 hours after surgery will be recorded for each patient using the VRS.
Participants/Inclusion and exclusion criteria
entry:
1. Conscious satisfaction in patients
2. No contraindications and allergies to remifentanil or labetalol
3. age between 80-18 years
4. Patients with physical condition (ASA) I - III Adults of both sexes
5. Definitive confirmation of non-pregnancy in female patients of reproductive age
6. Patients with addiction
7. Patients with a history of psychological illness
8. Patients with a history of taking beta-blockers or calcium channel blockers
No entry:
1. Patients with cardiac arrhythmias
2. Pregnant or lactating women
3. People with a history of alcohol or drug use in the past 3 months
4. Any other conditions or use of any medication that may interfere with the study
Intervention groups
In the labetalol group, 5 mg / ml of labetalol and in the remifentanil group, 1 μg / kg will be injected before the surgical incision. These judges will then be repeated for patients in each group to maintain hemodynamic stability during the operation (if the MAP is increased by more than 15% compared to baseline or HR> 80 times per minute).
Main outcome variables
Postoperative pain rate based on VRS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044924N3
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Reza Farahmandrad
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8852 2083
Email address
farahmandrad.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of labetalol and remifentanil on pain control after bariatric surgery
Public title
Comparative study of the effect of labetalol and remifentanil on pain control after bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) class I-II-III
No contraindications and allergies to remifentanil or labetalol
Exclusion criteria:
Patients with cardiac arrhythmias
Pregnant or Breastfeeding women
People with a history of alcohol or drug use in the last 3 months
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
By using the randomize number table, the patients were divided into two equal groups (n=25).
Blinding (investigator's opinion)
Double blinded
Blinding description
Both drugs are injectable, and the time of injection is during anesthesia. Therefore, patients in both groups are not aware of the type of drug. The outcome assessor is also unaware of how the drug is randomly assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat high way
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.IUMS.FMD.REC.1400.201
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
Upon entering recovery, 2, 4, 6 and 12 hours after surgery
Method of measurement
Verbal Ranking Scale (VRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lactalol group: In labetalol group, 5 mg / ml of labetalol will be injected to patients before surgical incision.
Category
Treatment - Drugs
2
Description
Intervention group: Remifentanil group: In remifentanil group, 1 microgram / kg will be injected to patients before surgical incision.