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Comparison of the effect of Lidocaine and Granisetron on postoperative nausea and vomiting in laparoscopic cholecystectomy

Protocol summary

Study aim
Comparison of the effect of lidocaine and granisetron on nausea and vomiting after laparoscopic cholecystectomy
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. Random allocation of samples to study groups is performed by block randomization method and by using R statistical software.
Settings and conduct
This double-blind clinical trial study will be performed on 120 patients undergoing laparoscopic cholecystectomy (in three groups of intervention 1, intervention 2, and control) in Ayatollah Mousavi Hospital in Zanjan. Random allocation of samples is perform by block method and using statistical software.Visual analog scale (VAS), Rhodes questionnaire and demographic information questionnaire will be used to assess the incidence and severity of postoperative nausea and vomiting.Questionnaires are completed by the researcher during the operation and at certain hours (recovery, 6, 12 and 24 hours after the operation).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age>18 years, American Society of Anesthesiologists Class (ASA Class) I & II, No history of motion sickness, No history of drug allergy, Laparoscopic cholecystectomy under general anesthesia, Body Mass Index<30, Non-smoking, Not receiving anti-nausea medication in the last 24 hours
Intervention groups
Patients in intervention group 1, at the end of the surgery (after discontinuation of anesthetic drugs) and before extubation, receiving 1.5 mg/kg of lidocain 2% (manufactured by Caspian Tamin Company) intravenously.Patients in intervention group 2, at the end of the surgery (after discontinuation of anesthetic drugs) and before extubation, receiving 3 mg of Granisetron (manufactured by Caspian Tamin Company) intravenously.Patients in control group dosn't receive medication.
Main outcome variables
Postoperative nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200910048678N1
Registration date: 2020-12-01, 1399/09/11
Registration timing: registered_while_recruiting

Last update: 2020-12-01, 1399/09/11
Update count: 0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
seyede fatemeh gheiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8338
Email address
fatemeh.gheiasi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-19, 1399/06/29
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Lidocaine and Granisetron on postoperative nausea and vomiting in laparoscopic cholecystectomy
Public title
Comparison of the effect of Lidocaine and Granisetron on postoperative nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age>18 year American Society of Anesthesiologists Class (ASA Class) I & II No history of motion sickness No history of drug allergy Laparoscopic cholecystectomy under general anesthesia Body Mass Index (BMI) <30 Non-smoking Not receiving anti-nausea medication in the last 24 hours
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples to study groups is done by block randomization method within a block size of 4. To be more accurate, block randomization is performed by using R statistical software and is provided for the researcher who is responsible for collecting samples, and participants are divided into three groups based on the code assigned to each treatment (A, B, C) without researcher's interference.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients know they are participating in a study that is aimed to evaluate the effect of Lidocaine and Granistrone on the treatment of postoperative nausea and vomiting but they are not informed that they receive Lidocaine or Granistrone or not receive any medication. Drugs are coded and the anesthesiologist who injects the drug are not aware of the medication that patients receive.
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
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.ZUMS.REC.1399.226

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
K81.9
ICD-10 code description
Cholecystitis, unspecified

Primary outcomes

1

Description
Postoperative nausea
Timepoint
Recovery, 6, 12 and 24 hours after surgery
Method of measurement
Rhodes Questionnaire, Visual Analogue Scale

2

Description
Postoperative vomiting
Timepoint
Recovery, 6, 12 and 24 hours after surgery
Method of measurement
Rhodes Questionnaire, Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Patients in intervention group 1, at the end of the surgery (after discontinuation of anesthetic drugs) and before extubation, receiving 1.5 mg/kg of lidocain 2% (manufactured by Caspian Tamin Company) intravenously.
Category
Treatment - Drugs

2

Description
Patients in intervention group 2, at the end of the surgery (after discontinuation of anesthetic drugs) and before extubation, receiving 3 mg of Granisetron (manufactured by Caspian Tamin Company) intravenously.
Category
Treatment - Drugs

3

Description
Control group: They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Seyede Fatemeh Gheiasi
Street address
Ayatollah Mousavi Educational and Medical Center, Gavazang, Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@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
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6400
Email
research@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
Seyede Fatemeh Gheiasi
Position
Educational staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mahdavi Blvd., Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8338
Email
fatemeh.gheiasi@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Gheiasi
Position
Educational staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mahdavi Blvd., Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8338
Email
fatemeh.gheiasi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Gheiasi
Position
Educational staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mahdavi Blvd., Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8338
Email
fatemeh.gheiasi@zums.ac.ir

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
There is no more information.
When the data will become available and for how long
There is no more information.
To whom data/document is available
There is no more information.
Under which criteria data/document could be used
There is no more information.
From where data/document is obtainable
There is no more information.
What processes are involved for a request to access data/document
There is no more information.
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