Comparative study of anesthesia with and without drug use on complications in patients undergoing cholecystectomy
Design
This randomized clinical trial with a parallel design, none blind and has a control group. This study is randomized, phase 3 study will be performed on 63 patients who are candidates for cholecystectomy. Random blocks are used for randomization and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be performed in Imam Reza Hospital of Kermanshah, is a double-blind. Researchers and participants were blinded by the allocation of study groups. Before the operation, patients will be asked for the necessary history and routine examinations and tests will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have not taken a long-acting analgesic in the last month; Patients who are not addicted.
Exclusion criteria:Patients with serious chronic diseases including diabetes, tuberculosis, epilepsy; cardiovascular and .. ; Patients who have received a vaccine or antidote within 1 month prior to screening
Intervention groups
In the first intervention group, anesthesia is performed using narcotics (Sufentanil Abu Reihan Company dose of half a microgram per kilogram of body weight by injection). In the second intervention group for anesthesia of patients from a combination of magnesium infusion for auxiliary analgesia and low dose ketamine for analgesia and dextmetomedin for sympatholysis Analgesia, anesthesia and lidocaine are used for laryngoscopy and non-irritation and ketorolac is used for pain during and after surgery.
Main outcome variables
Pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N177
Registration date:2021-10-23, 1400/08/01
Registration timing:registered_while_recruiting
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-11, 1400/07/19
Expected recruitment end date
2022-08-09, 1401/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of free opioid anesthesia and standard general anesthesia on the complication amount cholecystectomy patient
Public title
Comparison of anesthesia with and without drug use on complications in patients undergoing gallbladder surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have not taken a long-acting analgesic in the last month
Patients who are not addicted
Exclusion criteria:
Patients with serious chronic diseases including diabetes, tuberculosis, epilepsy; Cardiovascular and ..
Patients who have received a vaccine or antidote within 1 month prior to screening
Patients who have received an immunosuppressive drug one month before surgery
Patients who are allergic to morphine or morphine compounds
Pregnant people
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed.
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.KUMS.REC.1400.465
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Pain after surgery
Timepoint
5 hours after surgery, discharge time
Method of measurement
Based on Visual Pain Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, anesthesia is performed using narcotics (Sufentanil Abu Reihan Company dose of half a microgram per kilogram of body weight by injection).
Category
Treatment - Drugs
2
Description
In the second intervention group for anesthesia of patients from a combination of magnesium infusion (Samen company one to two mg) for auxiliary analgesia and low dose ketamine (Retekmedica company dose of 0.2 mg per kg body weight) for analgesia and dextmetomedin for sympatholysis Analgesia, anesthesia and lidocaine (Exir company dose of 1 mg per kilogram of body weight) are used for laryngoscopy and non-irritation and ketorolac (Abu Reihan company 60 mg) is used for pain during and after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Javad Alibakhshi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mjalibakhshi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Javad Alibakhshi
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mjalibakhshi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Alireza Ahmadi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Alireza.Ahmadi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Javad Alibakhshi
Position
Resident anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mjalibakhshi@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