Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery

Body Temperature Changes Clinical Trial

Official title:

Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948920
• Other study ID #: 07-59-07
• Secondary ID: TCTR20161017007
• Status: Completed
• Phase: N/A
• Start date: September 22, 2016
• Est. completion date: July 27, 2017

Study information

• Verified date: October 2018
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

Drug:
• Ephedrine
9 mg of ephedrine (3 ml)
• NSS
3 ml of normal saline

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Ramathibodi Hospital	Bankok	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tympanic temperature	Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups	120 minutes
Secondary	Blood pressure	Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups	120 minutes
Secondary	Shivering	After performing spinal anesthesia in 120 minutes duration	120 minutes