Comparison of Ondansetron and Granisetron Effects in the Prevention of Nausea and Vomiting in Patients Subjected to Laparoscopic Cholecystectomy Surgery
Design
Two arm parallel group randomized clinical trial, double blind
Settings and conduct
This study was non-control group with two groups receiving Ondansetron and Granisetron. This study was conducted at Shahid Mohammadi Hospital in Bandar Abbas.
Participants/Inclusion and exclusion criteria
Conditions for entering the study in a patient aged between 18-60 years with ASAI, II candidate for laparoscopic cholecystectomy who referred to Shahid Mohammadi Hospital in 1396-1393, and criteria for withdrawal, febrile illness, history of infection Pulmonary disease, Allergy to Endonestrone and Granisetron, pregnancy, inability to perceive VAS criteria for pain, The patient's consent for participation in the study was more than 120kg or less than 50kg.
Intervention groups
Patients were randomly divided into 2 groups. In a group of patients, 2 mg of Granisetron and another group received 4 mg of Endonestrone (in a total volume of 10 ml) 5 minutes before induction of anesthesia.
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170101031697N2
Registration date:2019-06-25, 1398/04/04
Registration timing:retrospective
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Afshin Parvizpanah
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6625
Email address
afshin.parvizpanah@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2016-03-21, 1395/01/02
Actual recruitment end date
2018-01-22, 1396/11/02
Trial completion date
2018-02-21, 1396/12/02
Scientific title
The efficacy of Ondansetron and Granisetron in preventing of post Laparascopic Cholesystectomy nausea and vomiting (PONV)
Public title
The efficacy of Ondansetron and Granisetron in preventing of post Laparascopic Cholesystectomy nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade one
Patients with ASA grade two
Patient were referred for laparoscopic cholecystectomy
Exclusion criteria:
Febrile illness
History of infection Pulmonary disease
Allergy to Endonestrone
Allergy to Granisetron
History of seizure
History of vascular contraction
Intracranial pressure
History of drug abuse
Patients who do not have proper collaboration during the study
History of digestive disease
Emergency patients Patients with a history of motion sickness (PTSD) or motion sickness (PONV) have a history of nausea and vomiting Surgery
Patients with history of nausea and vomiting during previous surgery
Patients who received anti-nausea and vomiting before surgery
Patients with hypothermia (below 36 ° C)
Pregnancy
Inability to perceive VAS criteria for pain
The patient's consent for participation in the study
Weight more than 120kg
Weight less than 50kg
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the patients, patients were randomly assigned to the study groups. Randomization was carried out in a sub-unit using statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pump syringes were prepared by an expert in the anesthetic room and the assistant did not know its content.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2017-09-20, 1396/06/29
Ethics committee reference number
IR.HUMS.REC.1394.120
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
nausea and vomiting
Timepoint
Patients were monitored for nausea and vomiting during recovery and after recovery for 24 hours during the hours (2-4-6-12-24).
Method of measurement
According to Clinical Obstetrician Anesthesiologist.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Patients in this group received 2 mg of Granisetron (in a total volume of 10 ml), 5 minutes before induction of anesthesia.
Category
Treatment - Drugs
2
Description
Second intervention group: Patients in this group received 4 mg of Ondansetron (in a total volume of 10 ml), 5 minutes before induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi hospital, Bandar Abbas;IRAN
Full name of responsible person
Said Kashani
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamour Aghamolai
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology , Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology , Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Said Kashani
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology , Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
Sdkashani486@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
SPSS file
When the data will become available and for how long
5/17/2019
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources
From where data/document is obtainable
Dr. Saeed Kashani Sdkashani486@gmail.com
What processes are involved for a request to access data/document