The present study was carried out with controlled clinical trials; triple blind on patients undergoing abdominal surgery (cholecystectomy and laparatomy) and under general anesthesia referring to Fatemi Hospital in the age range of 20 to 70 years old and on both males and females.
Participants/Inclusion and exclusion criteria
Inclusion criteria, eligible patients will be ASA1,2 physical. Severe cardiovascular disease, liver and kidney disorders, peptic ulcer, muscle disease, blood transfusions or blood products during surgery, or history of seizure, as well as surgeries with a duration of more than 2 hours as exclusion criteria.
Intervention groups
Tramadol 1 mg / kg and intravenous ibuprofen (800 mg ampoules) given in the same volume 30 minutes before surgery (injected over 10 minutes).
Main outcome variables
check in scale of shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180615040104N1
Registration date:2018-10-01, 1397/07/09
Registration timing:retrospective
Last update:2018-10-01, 1397/07/09
Update count:0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Maryam Mehrban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3363 1886
Email address
m.mehrban@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 intera venous Ibuprofen with Tramadol for prevention of postoperative shivering with general anesthesia
Public title
The effect of intravenous ibuprofen and tramadol on shivering after abdominal surgery with general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cholecystectomy (surgical)
Male patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 year.
Female patients referred to Ardabil Fatemi Hospital in the range of 20 to 70 year.
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 than 2 hours
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into three groups. Initially, 120 envelopes will be prepared that 40 with letters (A) and 40 with letters (B) and 40 envelopes with letters (E) written. The drugs will be encoding, so that the injector And the checklist registrar is not aware of the quiddity of the codes. The drugs are drawn in two Session (in volume of 2 cc) and in the same color of the syringes and the code is recorded on them. The technician outside of the research group prepares drugs and the researcher does not know the quiddity of the codes, type of injectable drugs and drugs are injected according to the selected code. Then an envelope is randomly selected and the drug that containing the code in the envelope is injected to the patient and the results are recorded in the checklist.
Blinding (investigator's opinion)
Triple blinded
Blinding description
At first three boxes with codes 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 selects one of the envelopes and injects and records the results in checklists.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical University of Ardebil
Street address
No. 90, Mlek Ashtar Alley, Otobosrani St., Ardebil City
City
Ardebil
Province
Ardabil
Postal code
5619866111
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR. ARUMS. REC. 1396. 228
Health conditions studied
1
Description of health condition studied
Cholelithiasis, cholecystitis and other diseases associated with gallbladder
ICD-10 code
k808,182
ICD-10 code description
Calculus of gallbladder with acute cholecystitis, Calculus of gallbladder with other cholecystitis, Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
check in scale of shivering
Timepoint
check in scale of post operative shivering based on observation muscle movement in recovery and scored
Method of measurement
score
Secondary outcomes
1
Description
check in scale of post operative nausea and vomiting and sedation and pain.
Timepoint
check in scale of post operative indication of nausea and vomiting and sedation and pain based on APFEL & RAMSAY score and VAS