Protocol summary

Summary
purpose:The purpose of this double blinded study was Comparison of ondansetron and meperidine for prevention of PAS in patients undergoing GA for lower extremity surgery.MethodsIn this clinical trial,105 patients with the age of 20-60 y/o and ASA class I,II,III were scheduled for elective orthopedic lower extremity surgery divided randomly assigned to one of three groups: intervention:M(meperidine),O(ondansetron),C(saline) After receieved premedication and immediately before the induction of anaesthesia;Sao2 recorded by pulse oxymeter.in first group,25mg Meperidine IV and in second group,4mg Ondansetron IV and in third group(control),2ml saline IV were administered immediately before the induction.GA in all patients induced equivalently with similar drugs and methods.all patients immediatly after emergence of GA and extubation transported to recovery room(PACU).in the times of 5 and 15 minutes after the enterance to recovery room,Sao2(by pulse oxymeter measurement) and shivering were assessed and recorded by nurse who was unaware of research methods.PAS control was graded with Wernch et al. system (0 = no shivering,1= muscle activity in only one muscle group,2= muscle activity in more than muscle group,3= shivering involving the whom body).Primary outcome measure: post operative cheels Primary outcome time point :twice( between five -fiftheen min) Primary outcome method of measurement :four point scale Inclusion: Graps Triminol ;20-60years old Inclusion cetria :Graps Triminol ;Asa class 1,2,3 ;Under going general anesthesia for lower extremity surgery exclusion cetria:Cardiovascular disease ,psychiatric dis, thyroid dis, drug allergic reaction - body temperature ≥ 38 or ≤ 36.3 ⁰ c – DM – obesity – procedures which require administration of blood and blood products & anticipated duration more than 180 min.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106096758N1
Registration date: 2011-08-13, 1390/05/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-13, 1390/05/22
Registrant information
Name
Mohammad Ghasem Roshanfekr Balalemi
Name of organization / entity
Qazvin , Universiti Of Medical and Health Science
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6002
Email address
mgroushanfekr@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor for research, qazvin universitiy of medical sciencesand health services
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ondansetron and meperidine for prevention of postoperative shivering in patients undergoing General Anesthesia for lower extremity surgery
Public title
Comparison of ondansetron and meperidine for prevention of postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Graps Triminol ;20-60years old ;Asa class 1,2,3 ;Under going general anesthesia for lower extremity surgery exclusion:Cardiovascular disease ,psychiatric dis, thyroid dis, drug allergic reaction - body temperature ≥ 38 or ≤ 36.3 ⁰ c – DM – obesity – procedures which require administration of blood and blood products & anticipated duration more than 180 min.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin universityof medical sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2010-03-20, 1388/12/29
Ethics committee reference number
28/20/4436

Health conditions studied

1

Description of health condition studied
Diseases of the nervous system
ICD-10 code
G90
ICD-10 code description
Disorders of autonomic nervous system

Primary outcomes

1

Description
post operative cheels
Timepoint
Twice(between 5-15min)
Method of measurement
4 point scale

Secondary outcomes

1

Description
sao2
Timepoint
-
Method of measurement
between 1-100

Intervention groups

1

Description
Intervention: :M(meperidine) 25mg /IV imediately before of induction .
Category
Prevention

2

Description
Intervention: O(ondansetron) 4mg /IV imediately before of induction
Category
Prevention

3

Description
Control: C(saline) 2mg /IV
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaid Rajee Hospital
Full name of responsible person
Dr Mohamad ghasem roshanfekr balalemi
Street address
Padeghan Street
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for research of Qazvin universityof medical science
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research of Qazvin universityof medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohamad Ghasem Roshanferkr Balalemi
Position
Assitant rezident
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 1332 0107
Fax
Email
mgroshanfekr@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin, University of Medical Sciences and Health Services
Full name of responsible person
Dr Hamid Kayalha
Position
Assitant professor/anesthesia
Other areas of specialty/work
Street address
Shahid bahonar Blv
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
H-Kayalha@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin universitiy of medical scince and health services
Full name of responsible person
Dr Mohammadghasem Roshanfekr balalemi
Position
resident anesthesia
Other areas of specialty/work
Street address
Shahid Bahonar Blv
City
Qazvin
Postal code
Phone
Fax
Email
Mgroushanfekr@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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