Prevention of postoperative shivering with general anesthesia
Design
A clinical trial randomized and triple blinded is performed on 120 patients
Settings and conduct
Field of study: Fatemi Hospital in Ardabil
A trial triple blinded randomized clinical is done on 120 patients. Outcomes are measure of shivering, nausea, vomiting and postoperative pain
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients undergoing cholecystectomy (surgical); male and female patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 years
Exclusion criteria: severe cardiovascular disease; Liver and Kidney disorders; peptic ulcer disease; muscular disease; patients with history of blood transfusions or blood products during surgery; patients with history of seizure; surgeries with a duration of more then 2 hours
Intervention groups
Interventions group 1: Intravenous Paracetamol ampoule 1 gr
Interventions group 2: Meperidine ampoule 30 mg
Control group: placebo( normal saline with the same volume and shape with the intervention
Main outcome variables
Check in scale of shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040597N1
Registration date:2018-10-31, 1397/08/09
Registration timing:retrospective
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Sara Ezati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 6063
Email address
s.ezati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-13, 1396/11/24
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons between effect of Intravenous Paracetamol with Meperidine for prevention of postoperative shivering with general anesthesia
Public title
The effect of Intravenous Paracetamol and Meperidine on shivering after abdominal surgery with general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cholecystectomy (surgical)
Patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 years
Exclusion criteria:
Severe cardiovascular disease
Liver and Kidney disorders
Peptic ulcer disease
Muscular disease
Patients with history of the blood transfusions or blood products during surgery
Patients with history of seizure
Surgeries with a duration of more then 2 hours
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Visitors are randomly divided into three groups, at first 120 envelopes have been prepared that containing 40 of them are written in letter A and 40th letter B and 40th letter C. Drugs are encoded so that the injector and the checklist completes are not aware of the nature of the codes. Medications are injected into the syringes in the same of volume and shape. Technician prepares medication and the researcher did not know the nature of the codes and type of drug. An envelope is selected randomly and injected drug inside of packet then the results are recorded in checklist,
Blinding (investigator's opinion)
Triple blinded
Blinding description
At first three boxes with A,B and C were prepared. Then the medications were given to an anesthetic technician. He was asked to place the vials of each drug in one of the boxes. Vials should be similar and without names. The packets are packed in each group and then the researcher randomly selected one of the envelopes and injects and records results in checklist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
No. 35/1, West Eslami3., Street Moallem
City
Ardebil
Province
Ardabil
Postal code
5613633681
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR. ARUMS. REC. 1396. 229
Health conditions studied
1
Description of health condition studied
cholelitiasis and cholesystitis and other disease associated with gallbladder
ICD-10 code
K808, 182
ICD-10 code description
Calculus of gallbladder with acute cholecystitis, calculus of gallbladder with other cholesystitis, calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Check in scale of shivering
Timepoint
Measurement at times 5, 15 minutes after entering the recovery
Method of measurement
Shivering Grading
Secondary outcomes
1
Description
check in scale of postoperative sedation
Timepoint
Measurement at times 5, 15 minuets after entering the recovery