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Comparing the effect of Pethidine, Ketamin and Ondansetron to prevent postoperative shivering in elective cholecyctectomy under general anesthesia

Protocol summary

Summary
The aim of this study is finding a proper alternative for Pethidine to prevent postoperative shivering.Inclision criteria are having Laparoscopic cholecyctectomy surgery and age between 20-50 years old. Exclusion criteria are smoking, addiction, cardiovascular disease, age less than 20 and age more than 50. In this randomized triple-blind clinical trial, 160 patients aged from 20-50 years with ASA class I & II undergoing elective cholecyctectomy are randomly divided into four equal groups. Anesthesia procedure is similar in all groups.15 minutes before the end of surgery ,0.4mg/kg pethidine, 0.25mg/kg ketamin , 0.1mg/kg ondansetron and normal saline , is injected randomly to the groups. Hemodynamic changes (systolic blood pressure, diastolic blood pressure, and heart rate), body temperature (before injection, 5 minutes after injection, and after stability), and nausea & vomiting after surgery are measured and compared betweeen groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016032326340N1
Registration date: 2016-03-23, 1395/01/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Nasim Zarrin
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 2024
Email address
n.zarin@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Pethidine, Ketamin and Ondansetron to prevent postoperative shivering in elective cholecyctectomy under general anesthesia
Public title
Comparing the effect of Pethidine, Ketamin and Ondansetron to prevent postoperative shivering in elective removal of gallbladder under general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclision criteria: Having Laparoscopic cholecyctectomy surgery; age between 20-50 Exclusion criteria: Smoking; addiction; cardiovascular disease; age less than 20; age more than 50
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Boulvar
City
Qazvin
Postal code
3419915315
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
20/9884/د

Health conditions studied

1

Description of health condition studied
Prevention of postoperative shivering
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified

Primary outcomes

1

Description
Diastolic Blood Pressure
Timepoint
before injection, 5 minutes after injection, after stability in recovery
Method of measurement
check list

2

Description
Heart Rate
Timepoint
before injection, 5 minutes after injection, after stability in recovery
Method of measurement
check list

3

Description
Body Temperature
Timepoint
before injection, 5 minutes after injection, after stability in recovery
Method of measurement
check list

4

Description
nausea and vomiting
Timepoint
postoperative
Method of measurement
check list

5

Description
shivering
Timepoint
postoperative
Method of measurement
check list

6

Description
systolic blood pressure
Timepoint
before injection,5 minutes after injection, after stability in recovery
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Group A; Received Pethidine 0.4 mg/ kg
Category
Treatment - Drugs

2

Description
Group B; Received Ketamin 0.25 mg/kg
Category
Treatment - Drugs

3

Description
Group C; Received Ondansetron 0.1 mg/kg
Category
Treatment - Drugs

4

Description
Group D; Received Normal Saline 2 cc
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital of Qazvin
Full name of responsible person
Dr Nasim Zarrin
Street address
Qazvin, Minoodar, across from Elahiye Restaurant
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Marzie Beighom Khezri
Street address
Shahid Bahonar Boulvar ,Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Nasim Zarrin
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 42, MehrdadAalley, Padegan Street, Qazvin
City
Qazvin
Postal code
3413993354
Phone
+33 342024
Fax
Email
zarrinnasim@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Nasim Zarrin
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 42, Mehrdad Alley, Padegan Street, Qazvin
City
Qazvin
Postal code
3413993354
Phone
+98 28 3334 2024
Fax
Email
zarrinnasim@gmail.comn.zarin@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Nasim Zarrin
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
No 42, Mehrdad Alley, Padegan Street, Qazvin
City
Qazvin
Postal code
3413993354
Phone
+98 28 3334 2024
Fax
Email
zarrinnasim@gmail.comn.zarin@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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