Protocol summary

Summary
Comparison of effects of ondansetron and meperidine on postanesthesia shivering treatment is the goal of this study. inclusion criteria are ASA I,II patients with postanesthesia shivering after laparatomic surgeries, no respons to surface warming , shivering score more than 1 . Exclusion criteria are age less than 20 and more than 60 years old,hepatic disease,drug alergic reactions,history of prolonged QT syndrom in relatives, history of pulmonary disease, convulsion,alergy to narcotics, consumption of Tricyclic Antidepressants or Monoamine oxidase inhibitors , elevated Intracranial Pressure , sever renal disease, hypothiroidism,narcotic drug addiction. Population of study is the patients with postanesthesia shivering in recovery room of firoozgar hospital. Total sample size is 40 and the trial is double blinded. Drug intervention is injection of 8 milligram ondansetron intravenously or 25 milligram meperidine intravenously in recovery room to control postoperative shivering. Final aim of the study is to define the success rate of ondansetron in treatment of shivering and comparison of the time to end shivering between 2 drugs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109224969N3
Registration date: 2012-01-11, 1390/10/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-11, 1390/10/21
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of ondansetron and meperidine in treatment of postanesthetic shivering in patients under laparatomy surgeries with general anesthesia
Public title
comparison of ondansetron and meperidine in treatment of postanesthetic shivering in patients under laparatomy surgeries with general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : ASA I,II patients betwwen with postoperative shivering; no respons to surface warming; shivering score more than 1 exclusion criteria: age less than 20 and more than 60 y. Contraindication of Ondansetron; hepatic disease; drug alergic reactions; history of prolonged QT syndrom in relatives; contraindication of meperidin; history of pulmonary disease; convulsion; alergy to narcotics; consumption of Tricyclic Antidepressants or Mono Amino Oxydase Inhibitors; elevated Intracranial Pressure; sever renal disease; hypothiroidism; narcotic drug addiction.
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: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Ghods st.- Keshavarz blvd.
City
Tehran
Postal code
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
42887-12966-30-03-90

Health conditions studied

1

Description of health condition studied
Post anesthesia shivering
ICD-10 code
T88.5
ICD-10 code description
Hypothermia following anaesthesia

Primary outcomes

1

Description
control of postanesthesia shivering
Timepoint
after 10 minutes
Method of measurement
shivering score ( 1-4 )

Secondary outcomes

1

Description
exact time of ending of shivering
Timepoint
every 1 minutes until minute 10
Method of measurement
shivering score(1 to 4 )

Intervention groups

1

Description
intravenous injection of 25 milligram meperidine
Category
Treatment - Drugs

2

Description
intravenous injection of 8 milligram Ondansetron
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Beh Afarin st. Karim Khan blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Shohreh Asadi
Street address
Poursina st.- Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Alireza Pournajafian
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan blvd.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-pournajafian@tums.ac.ir alipn78@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Alireza Pournajafian
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan blvd.
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-pournajafian@tums.ac.ir alipn78@yahoo.com
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
Loading...