Comparing the effect of Amino acids infusion with placebo to prevent postoperative shivering in women aged from 20 to 50 years old undergoing Laparoscopic Cholecystectomy
The aim of this study is to evaluate the effect of intravenous Amino acids to prevent postoperative shivering in women undergoing Laparoscopic Cholecystectomy. This is a randomized controlled clinical trial that will perform on 80 female patients aged from 20-50 years old undergoing Laparoscopic Cholecystectomy in Velayat hospital of Qazvin. In this study, patients are in ASA class I and II. This is a double blind study (physicians and patients are not aware that how the distribution of infusion is). Patients were randomly divided into two groups on the basis of selection of colored cards. Before induction of anesthesia, heart rate, blood pressure, arterial oxygen saturation and oral temperature of patients will be measured and recorded in both groups. General anesthesia will be performed for all patients with similar method. Immediately after induction of anesthesia, control group will receive normal Saline infusion (placebo) and case group will receive Amino acid infusion 10% (2ml/kg/h maximum 1mg/kg) for each patient until the end of surgery. After entering the recovery heart rate, blood pressure, arterial oxygen saturation, oral temperature, and postoperative shivering (by clinical observation and on the basis of a similar grading system) will be recorded at 10, 20 and 30 minutes. The Case group and control group will be compared with each other in the end.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010925676N2
Registration date:2016-05-11, 1395/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Hamid Kayalha
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1007
Email address
hkayalha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-07-13, 1394/04/22
Expected recruitment end date
2015-12-13, 1394/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Amino acids infusion with placebo to prevent postoperative shivering in women aged from 20 to 50 years old undergoing Laparoscopic Cholecystectomy
Public title
The effect of amino acids in the prevention of postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Female patients aged from 20 to 50 years old; patients with ASA class I and II having elective laparoscopic cholecystectomy; consent to participate up to the end of study.
Exclusion criteria: Patients with ASA class more than 2; Using Corticosteroids or No steroidal anti-inflammatory drugs(NSAID); body temperature more than 38 and less than 36.3 centigrade degrees; sensitivity to amino acids; obesity; surgery duration less than 1.5 or more than 2.5 hour; Hemodynamic changes more than 20%; prescribing blood or blood products during surgery.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of the University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
3419759811
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.QUMS.REC.1394.217
Health conditions studied
1
Description of health condition studied
Postoperative shivering
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
Postoperative shivering
Timepoint
After entering the recovery, every 10 min to 30 min
Method of measurement
Clinical observation
2
Description
Arterial oxygen saturation
Timepoint
After entering the recovery, every 10 min until 30 min
Method of measurement
By monitoring devise
Secondary outcomes
empty
Intervention groups
1
Description
Immediately after induction of anesthesia, infusion of Amino acid 10% (2ml/kg/h maximum 1mg/kg) will begin for each of the patients in the case group, and will continue until the end of surgery.
Category
Prevention
2
Description
Immediately after induction of anesthesia, infusion of saline began for each of the patients in the control group (C) and were continued until the end of surgery.