The objective of the present study is to compare the effectiveness of meperedine and ondansetron in the treatment of post–anesthesia shivering. A total of 200 patients who meet eligibility criteria and develop shivering after general or regional anesthesia will be recruited and assigned to receive meperedine 4 mg/kg, Ondansetron, 4 mg, or Normal Saline 4 cc. Primary outcome is stop of shivering and adverse effects during recovery stay and also adverse effects related to study drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107237093N1
Registration date:2011-09-11, 1390/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-11, 1390/06/20
Registrant information
Name
Mohsen Saber Moghadamranjbar
Name of organization / entity
North khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 4229 7069
Email address
sabermoghadam41@nkh-cms.ac.ir
Recruitment status
Recruitment complete
Funding source
North khorasan University Of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ondansetrone and meperedin for treatment of post anaesthesia shivering – A randomized controlled clinical trial
Public title
comparing the effect of meperidine and ondansetron in treatment of post anesthesia shivering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA 1 and 2; age 18-65; uncomplicated surgery and anesthesia; all types of surgery; all types of anesthesia
Exclusion criteria: complicated anesthesia and surgery; required blood transfusion; taking drugs in pre-anesthesia period (ondansetron, pethedine); opium based anesthesia; addiction; pre-anesthesia hypothermia (less than36c) or hyperpyrexia (more than 38c); obesity (more than 100kg or BMI more than 35); hypo or hyperthyroidism; parkinson; Reynaud syndrome and diagnosis of dysautonomia; post-operative hypotension more than 20%; known allergy to ondansetron or pethedin; post operative nausea & vomiting; taking benzodiazepines in recovery room
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
North khorasan University Of Medical Sciences Ethics Committe
Street address
South Shariati 7, Deputy Of Education, North khorasan University Of Medical Sciences, Bojnurd
City
Bojnurd
Postal code
Approval date
2010-11-23, 1389/09/02
Ethics committee reference number
89/p/182
Health conditions studied
1
Description of health condition studied
post anesthesia shivering
ICD-10 code
Y60, Y69
ICD-10 code description
Misadventures to patients during surgical and medical care
Primary outcomes
1
Description
post anesthesia shivering
Timepoint
continuously during recovery stay
Method of measurement
Questionnaire
Secondary outcomes
1
Description
response to treatment
Timepoint
immediately after injection of drugs
Method of measurement
inspection- questionnaire
Intervention groups
1
Description
Intervention group1: meperedine 4mg/kg=4cc
Category
Treatment - Drugs
2
Description
Intervention group 2: ondansetron 4mg=4cc
Category
Treatment - Drugs
3
Description
Control group: normal saline 4 cc
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Mohsen Sabermoghadam
Street address
Imam ali Hospital
City
Bojnurd
2
Recruitment center
Name of recruitment center
Bentolhoda Hospital
Full name of responsible person
Street address
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North khorasan University Of Medical Sciences
Full name of responsible person
Hamid Hoseini
Street address
South Shariati 7- Deputy Of Education And Research
City
Bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North khorasan University Of Medical Sciences
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
Imam Ali Hospital
Full name of responsible person
Dr Mohsen Sabermoghadam
Position
Assistant Professor-Anesthesiologist
Other areas of specialty/work
Street address
Imam Ali Hospital
City
Bojnurd
Postal code
Phone
+98 58 4224 6739
Fax
+98 58 4224 6739
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Ali Hospital
Full name of responsible person
Dr Mohsen Sabermoghadam
Position
Assistant Professor-Anesthesiologist
Other areas of specialty/work
Street address
Imam Ali Hospital
City
Bojnurd
Postal code
Phone
+98 58 4224 6739
Fax
+98 58 4224 6739
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)