A Comparison of the preventive effect of 100 mg and 200 mg oral celecoxib on shivering during and after orthopedic lower extremity surgery under the spinal anesthesia in patients and the control group
This study aimed to compare the anti-shivering effects of 100 mg and 200 mg of this drug in the control group undergoing orthopedic lower extremity surgeries under spinal anesthesia and the patients with American Society of Anesthesiologists (ASA) 1.
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
In this simple randomized double blind clinical trial that was conducted at Ayatollah Kashani Hospital in Isfahan on control group, patients undergoing elective orthopedic surgery of the lower extremity under spinal anesthesia as well as patients with ASA1 were evaluated. The first group of patients received Celecoxib 100mg three hours before SA. The second group received Celecoxib 200mg three hours before SA, and the third group received placebo three hours before SA. The incidence and severity of shivering is measured 10 minutes after SA, and subsequently at 15 minutes intervals till the end of surgery in all three groups. The medications were coded to prevent any bias. The coded medications were given by the first Anesthesiologist, and the data were recorded by the second Anesthesiologist.
Participants/Inclusion and exclusion criteria
Participants: the patients undergoing elective orthopedic surgery of the lower extremity under spinal anesthesia
Entry condition: patients with ASA1, age between 18 and 65
No-entry conditions: history of hypertension; cardiovascular disease; allergy to Coxib drugs; ...
Intervention groups
first group is received Celecoxib 100 mg, second group Celecoxib 200 mg and third group is received placebo
Main outcome variables
Incidence and severity of shivering during the operation and the recovery period based on Tsai and Cha scale
General information
Reason for update
Acronym
spinal
IRCT registration information
IRCT registration number:IRCT20101211005362N23
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-21, 1396/02/31
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-05-21, 1396/02/31
Trial completion date
2017-05-21, 1396/02/31
Scientific title
A Comparison of the preventive effect of 100 mg and 200 mg oral celecoxib on shivering during and after orthopedic lower extremity surgery under the spinal anesthesia in patients and the control group
Public title
oral celecoxib on shivering during and after orthopedic lower extremity surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patients with American Society of Anesthesiologists (ASA) 1
age between 18 and 65
Exclusion criteria:
History of hypertension
Sever cardiovascular disease
Allergy to Coxib drugs
Psychological disorder based on history
Temperature less than 36 or more than 38 Celsius degree
Usage of alcohol and opioids
Usage of vasodilators
Allergy to Aspirin
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation. Numbered balls from 1 to 105 were put in a box. Then were pulled out randomly and the number was written in a group of Celecoxib 100 mg, Celecoxib 200 mg and placebo, respectively. Each number represented the order of patients entry to the hospital and had the entrance requirements and had given the consent for entering to the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
بي حسي نخاعي در فضاي L3-L4با ماركائين 5/0% با سوزن 22G Quincke spinal انجام گرفت.كپسولهاي celecoxib با كد خاص 3 ساعت قبل از SA به بيمار داده شد. اين كار توسط متخصص بيهوشي اول انجام و دادهها توسط متخصص بيهوشي دوم از طريق پرسشنامه جمعآوري و بدين طريق كورسازي صورت ميگرفت
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical science, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
81857647852
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.MUI.MED.REC.1396.260
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
T88.51
ICD-10 code description
Hypothermia following anesthesia
Primary outcomes
1
Description
Incidence and severity of shivering based on Tsai and Cha scale
Timepoint
every 15 minutes
Method of measurement
objective
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: received Celecoxib 100mg three hours before operation.
Category
Treatment - Drugs
2
Description
Second intervention group: received Celecoxib 200mg three hours before operation.
Category
Treatment - Drugs
3
Description
Control group: received placebo three hours before operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Seyed Mohamadreza Safavi
Street address
Alzahra hospital, Sofeh Avenue
City
Isfahan
Province
Isfehan
Postal code
8178663521
Phone
+98 31 3620 1992
Email
safavi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjouy Javanmard
Street address
Isfahan University of Medical Science, Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?