Determination and comparison between prophylactic use of ondansetron - meperidine and midazolam on shivering after laparoscopic cholecystectomy.
Design
Triple blind randomized clinical trial with control group -160 patients -defined with random allocation software to 4 groups.Patient do not know his group.Data collector do not know too.Also data analyzer.(double blind)
Settings and conduct
According to usefulness of these drugs in reducing of shivering after surgery and not being comparison between them in this research we compare use of them in reducing shiver after surgery in Alzahra Hospital in Isfahan.After sleeping on surgical bed and monitoring anesthesia will be inducted.After tracheal intubation anesthesia continues.30 mins to the end of surgery in A-B-C-D group respectively use midazolam - ondansetron - petedine with mentioned doses and the last group as control group. Shivering will be graded in recovery.Patient do not know his group.Data collector and also data analyzer do not know too.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people between 20 to 70 years old - patient satisfaction -ASA 1-2
Exclusion criteria : infectious disease - neuromascular disease - addiction - heart failure - chronic mental disease that needs drug - use of alpha and beta blocker - temperature above 38 and below 36.5
Intervention groups
All three drugs will be administered 30 minutes to the end of surgery. In the first group 75 microgram/kg of midazolam will be used.In some researches midazolam cure shivering after surgery.In the second administer 8 mg ondansetron.It is usefull in reducing post operative shivering ,too.Second group use 0.5 mg/kg petedine .Use of this drug in different doses are useful in prevention and cure of post operative shivering.Last group as control group and comparison with others do not give any drug.
Main outcome variables
Shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100926004819N5
Registration date:2022-01-16, 1400/10/26
Registration timing:registered_while_recruiting
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Saied Morteza Heidari Tabaei Zavareh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1267 6415
Email address
m_heidari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the prophylactic use of Ondansetron - Meperidine and Midazolam on shivering after laparoscopic cholecystectomy under general anesthesia
Public title
Comparison between Ondansetron - Meperidine and Midazolam on postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidate for laparoscopic cholecystectomy
Patient satisfaction for participation
ASA1/2
Exclusion criteria:
Infectious disease
Neuromuscular disease
Drug addiction
Hurt failure (EF<40%)
Chronic mental illness that needs drug
Use of alpha and beta blocker
Temperature above 38 and below 36.5
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with simple randomization. Also randomization unit is individual.We do not use stratified randomization. Randomization tool is SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient do not know his group.
The person who collect data don,t know it.
The person who analyze statistics don,t know too.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University Of Medical Sciences
Street address
Ethics commitee of Isfahan University of Medical Sciences;Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IR.MUI.MED.REC.1400.318
Health conditions studied
1
Description of health condition studied
shivering after laparoscopic cholecystectomy
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
shivering under crossley classification
Timepoint
after 15-30-45-60 minute in recovery
Method of measurement
crossley classification
2
Description
intensity of pain after surgury
Timepoint
after 15-30-45-60 minute in recovery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For comparison with patients who give petedine - midazolam or ondansetron with mentioned doses as single dose 30 mins to the end of laparoscopic cholecystectomy and as control group in this level they do not give any drug.Other processes in this group are the same as other groups.
Category
Prevention
2
Description
Intervention group:They give 75 microgram/kg midazolam 30 mins to the end of laparoscopic cholecystectomy as single dose.Midazolex 5,15(midazolam ampule 5,15 mg/ml)made in Exir pharmacy as intravenous injection.
Category
Prevention
3
Description
Intervention group: 30 mins to the end of laparoscopic cholecystectomy 8 mg Ondansetron as single intravenous dose.Exir Ondansetron 8 will be used.Ondansetron ampule as 2 mg/ml(2,4 ml) is in the market.
Category
Prevention
4
Description
Intervention group:30 mins to the end of laparoscopic cholecystectomy Petedine 0.5 mg/kg as single intravenous dose.Petedine 50, 100 ampules are made in Exir company that are 50 , 100 mg/ml(1 , 2 ml).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Navid Mirsatari
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
m_heidari@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
دکتر مژگان مرتضوی
Street address
No 4 Building ; Isfahan medical sciences university ; Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
reasearch@mui.ac.ir
Web page address
https://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Saied Morteza Heidari Tabaei Zavareh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1267 6415
Fax
+98 31 1266 0948
Email
m_heidari@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saied Morteza Heidari Tabaei Zavareh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1267 6415
Fax
+98 31 1266 0948
Email
m_heidari@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saied Morteza Heidari Tabaei Zavareh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1267 6415
Fax
+98 31 1266 0948
Email
m_heidari@med.mui.ac.ir
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
Yes - There is 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
Research data will be shared after patients become unrecognizable
When the data will become available and for how long
reachable after 2022
To whom data/document is available
Researchers in the universities and scientific centers
Under which criteria data/document could be used
medical sciences researchers for clinical use or more researches
From where data/document is obtainable
Hezarjarib Ave -Isfahan Medical University or Email:
m_heidari@med.mui.ac.ir
What processes are involved for a request to access data/document
Isfahan Medical University library or Email address