Effects of Preoperative Ondansetron and Clonazepam on Postoperative Nausea and Vomiting after Laparoscopic Cholecystectomy; A Randomized Double-Blind, Placebo Controlled Trial
The aim of the current study is to compare the efficacy of ondansetron and clonazepam in reducing the incidence and severity of PONV and postoperative pain in patients undergoing LC.
Design
In this research, 90 eligible patients referring to Shahid Faghihi hospital were chosen purposefully and were randomly divided into 3 groups of first and second interventions and control. Groups allocation were concealed by assigning a unique code to each participants.
Settings and conduct
Shahid Faghihi hospital, a tertiary healthcare center affiliated with Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients scheduled for elective LC, having an American Society of Anesthesiologists (ASA) physical status of I or II, between 18 and 65 years of age.
Exclusion criteria: patients with body mass index (BMI) more than 30 kg/m2, history of previous severe PONV, history of motion sickness, significant gastrointestinal problems, recent antiemetic drugs consumption, smokers, impaired kidney or liver functions and menstruating, pregnant or lactating females, migraine or cluster headaches, mental retardation or psychiatric disorder and those with chronic alcohol consumption.
Intervention groups
First study group receive 2 mg of oral clonazepam and intravenous injection of placebo 15-minute prior to induction of anesthesia
Second group receive 4 mg intravenous injection of ondansetron and oral tablets of placebo in the same time window
Control group receive oral and intravenous injection of placebo accordingly
Main outcome variables
Normal vaginal delivery (NVD) percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090912002445N6
Registration date:2018-01-22, 1396/11/02
Registration timing:registered_while_recruiting
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Preoperative Ondansetron and Clonazepam on Postoperative Nausea and Vomiting after Laparoscopic Cholecystectomy; A Randomized Double-Blind, Placebo Controlled Trial
Public title
Effects of Ondansetron and Clonazepam on Nausea and Vomiting after Laparoscopic Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
between 18 and 65 years of age.
Having American Society of Anesthesiologists (ASA) physical status of I or II
Exclusion criteria:
Patients with body mass index (BMI) more than 30 kg/m2
history of previous severe Post-Operative Nausea and Vomiting (PONV)
history of motion sickness
significant gastrointestinal problems
recent antiemetic drugs consumption
smokers
impaired kidney or liver functions and menstruating
pregnant or lactating females
migraine or cluster headaches
mental retardation
psychiatric disorder
chronic alcohol consumption
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The included patients were randomly assigned to 3 study groups using a computer-based random digit generator utilizing the admission numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
All the patients and physicians administrating the medications will blinded toward the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Province
Fars
Postal code
71973–11351
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
IR.SUMS.MED.REC.1394.321
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea`
Timepoint
1, 3, 6, 12 and 24 hours after the operation
Method of measurement
10-measure visual analogue scale (VAS)
2
Description
Severity of pain
Timepoint
1, 3, 6, 12 and 24 hours after the operation
Method of measurement
10-measure visual analogue scale (VAS)
3
Description
Vomiting
Timepoint
First 12 hours after the operation
Method of measurement
Record of vomiting incidence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 mg of oral clonazepam (Sobhan Darou Inc., rasht, Iran) and intravenous injection of placebo 15-minute prior to induction of anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: 4 mg intravenous injection of ondansetron (Alborz Darou Inc, Tehran, Iran) and oral tablets of placebo
Category
Treatment - Drugs
3
Description
Control group: oral and intravenous injection of placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Reza Raeesi Estabragh
Street address
Zand Avenue, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdolkhalegh Keshavarzi
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3212 2204
Email
keshavarzi.ak@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Reza Raeesi Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Nemazi Hospital, Zand Avenue, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Raeesi Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Nemazi Hospital, Zand Avenue, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
r.raeesi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Raeesi Estabragh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Nemazi Hospital, Zand Avenue, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
r.raeesi@yahoo.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