Body Temperature ChangesNCT02948920
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
A study testing Ephedrine and NSS in people with Body Temperature Changes, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- Ephedrine and NSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 22 Sep 2016to 27 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Ramathibodi Hospital
Bangkok, Bangkok, 10400
About this study
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.
Read the 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)
- Conditions
- Body Temperature Changes
- Being tested
- Ephedrine, NSS
- Keywords
- ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering
- Medical subject headings
- Body Temperature Changes, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Experimental
9 mg of ephedrine (3 ml)
NSSDrug
Also called Control
3 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | Experimental | Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia Receives: Drug: Ephedrine |
| NSS | Placebo comparator | Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia Receives: Drug: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic temperature
Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups
Measured: 120 minutes
Secondary outcomes (2)
Blood pressure
Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups
Measured: 120 minutes
Shivering
After performing spinal anesthesia in 120 minutes duration
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start22 Sep 2016
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanist Pravitharangul, Ramathibodi Hospital
- Investigators
- Thanist Pravitharangul, MD, Principal investigator, Department of Anesthesiology, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948920
- Sponsor's protocol ID
- 07-59-07
- Other IDs
- TCTR20161017007
- Status last verified
- Oct 2018
- First submitted
- 27 Oct 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
- ClinicalTrials.gov ID
- NCT02948920
- Acronym / sponsor ID
- 07-59-07
- Conditions
- Body Temperature Changes
- Keywords
- ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | Experimental | Drug: EphedrineIntravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia |
| NSS | Placebo comparator | Drug: NSSIntravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EphedrineAlso: Experimental9 mg of ephedrine (3 ml) | Drug | Ephedrine |
| NSSAlso: Control3 ml of normal saline | Drug | NSS |
Primary outcome
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
2 secondary outcomes
Blood pressure
Time frame: 120 minutes
Shivering
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- BackgroundThanist 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanist Pravitharangul, MD principal investigator
Department of Anesthesiology, Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ephedrine and NSS in people with Body Temperature Changes, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanic temperature (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.