Comparison of postoperative analgesic effect of Magnesium sulfate and Gabapentin in patients undergoing laparoscopic cholecystectomy in Musavi hospital of Zanjan in 2019
Determine the postoperative analgesic effect of Magnesium sulfate and Gabapentin in patients undergoing laparoscopic cholecystectomy in Musavi hospital of Zanajn in 2019
Design
Simple randomized, controlled clinical trial of Gabapentin and Magnesium sulfate
Settings and conduct
The trial will be performed after confirming of the code of ethics and registration in IRCT at Ayatollah Mousavi Hospital in Zanjan in patients undergoing laparoscopic cholecystectomy. In pre-operative visit will provide training on how to express pain and how to work with visual analogue scale. Random cases will be divided into 3groups of 30 people.The control group will not receive any interventions.In gabapentin group, 600mg of gabapentin will be given an hour before surgery .In the magnesium sulfate group,50mg/kg magnesium will be infused within 100ml of normal saline during one hour per-operation. After operation using the VAS visual scale every 15minutes till 1 hour and every 6hours till 24hours for checking pain. At each stage, in the case of a larger vas than 4, they will be given 25mg pethidine. After data collection, amount of drug use and VAS index will be compared statistically between the 3 groups.
Participants/Inclusion and exclusion criteria
Age 18-65/ ASA class 1,2/ BMI less than 30/ No allergy to medication/ lack of history of cardiac arrhytmia and hepatic and renal disfunction / normal creatinine/no pregnancy or breastfeeding/no use of analgesics/no use of analgesics/absence of neuromuscular diseases
Intervention groups
There will be no intervention in Control group, in Gabapentin group they will be given 600mg gabapentin one hour before surgery, in Magnesium sulfate group they will be infusioned 50mg/kg Magnesium sulfate in 100ml normal saline one hour per-surgery
Main outcome variables
Pain by VAS; Time of first need of analgesics; Overall consume of analgesics
General information
Reason for update
Acronym
VAS (Visual Analogue Scale)
IRCT registration information
IRCT registration number:IRCT20160818029414N6
Registration date:2019-10-21, 1398/07/29
Registration timing:registered_while_recruiting
Last update:2019-10-21, 1398/07/29
Update count:0
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Vahideh Rashtchi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 341 1683
Email address
rashtchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative analgesic effect of Magnesium sulfate and Gabapentin in patients undergoing laparoscopic cholecystectomy in Musavi hospital of Zanjan in 2019
Public title
Effect of Magnesium sulfate and Gabapentin in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
ASA |-||
BMI less than 30
Normal creatinine
Exclusion criteria:
Allergy to medication
History of cardiac arrhythmia and hepatic renal impairment
pregnancy or breastfeeding
use of analgesics
use of NSAIDs
Existence of neuromuscular disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with use of sample vollume formula and comparison of a qualitative trait in groups
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 Zanjan University of Medical Sciences
Street address
Floor 5, No. 106, 25th Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
1998869153
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.ZUMS.REC.1398.178
Health conditions studied
1
Description of health condition studied
Laparoscopic Cholecystectomy
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
Primary outcomes
1
Description
Post operative pain
Timepoint
After surgery every 15minutes till 1hour and then every 6hours till 24hours
Method of measurement
Visual analogue scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gabapentin group: one hour before surgery patient will be taken 600mg gabapentin(2 300mg capsule)
Category
Treatment - Drugs
2
Description
Intervention group: Magnesium sulfate group: 50mg/kg magnesium sulfate in 100ml normal saline will be infused to patients in one hour during surgery.
Category
Treatment - Drugs
3
Description
Control group: No medication will be taken .
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Musavi hospital
Full name of responsible person
Dr Vahideh Rashtchi
Street address
Musavi hospital, Gavazang road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Rashtchi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Azadi Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3133 0000
Email
Rashtchi@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Bita Barghi
Position
Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Floor 5, No.106, 25th Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
1998869153
Phone
+98 21 8868 8444
Email
bita.b7513@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Vahideh Rashtchi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Musavi hospital, Gavazang Ave., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Rashtchi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Bita Barghi
Position
Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Floor 5, No. 106, 25th Ave., Saadatabad
City
Tehran
Province
Tehran
Postal code
1998869153
Phone
+98 21 8868 8444
Email
bita.b7513@Gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available