- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02948920
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
October 5, 2018 updated by: Thanist Pravitharangul, Ramathibodi Hospital
A prospective double-blinded randomized controlled study to determine efficacy of ephedrine in preserving core temperature in patients under neuraxial spinal anesthesia for knee and ankle arthroscopic surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To determine the effect of ephedrine on preserving core temperature (tympanic) when given at finishing of local anesthetic administration for spinal neuraxial anesthesia comparing to normal saline (120 minutes period)
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bankok, Bangkok, Thailand, 10400
- Department of Anesthesiology, Ramathibodi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient undergoing knee or ankle arthroscopic surgery under spinal block at department of orthopaedic Ramathibodi Hospital
- BMI 17-30 kg/m2
- ASA physical status 1-3
- Age 18-70
- Last oral intake more than 6 hours (2 hours for water)
- Consent form acquired
Exclusion Criteria:
- Patient who are contraindicated for spinal block
- Anesthesia level higher than T4 or lower than T10
- Tympanic temperature more than 37.5 or less than 35.5 degrees Celsius
- Otitis or other ear infection
- Patients who receive alpha adrenergic blocker or beta adrenergic blocker
- Initial blood pressure presenting in operating theater 140 90 mmHg repeat after rest 5 minutes
- Patient refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ephedrine
Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia
|
9 mg of ephedrine (3 ml)
Other Names:
|
Placebo Comparator: NSS
Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia
|
3 ml of normal saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tympanic temperature
Time Frame: 120 minutes
|
Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 120 minutes
|
Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups
|
120 minutes
|
Shivering
Time Frame: 120 minutes
|
After performing spinal anesthesia in 120 minutes duration
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thanist Pravitharangul, MD, Department of Anesthesiology, Ramathibodi Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thanist Pravitharangul, Wirakorn Koopinpaitoon, Rungruedee Kraisen, Rojnarin Komonhirun. Ephedrine and propofol for induction of general anesthesia can decrease intraoperative hypothermia in patients undergoing plastic and breast surgery: a randomized, controlled trial. Asian Biomedicine Vol. 9 No. 3 June 2015; 379 - 385
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2016
Primary Completion (Actual)
July 27, 2017
Study Completion (Actual)
July 27, 2017
Study Registration Dates
First Submitted
October 27, 2016
First Submitted That Met QC Criteria
October 27, 2016
First Posted (Estimate)
October 31, 2016
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-59-07
- TCTR20161017007 (Registry Identifier: Thai Clinical Trials Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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