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

Not Applicable

Completed

• Conditions: Body Temperature Changes
• Interventions: Drug: Ephedrine; Drug: NSS

• Registration Number: NCT02948920
• Lead Sponsor: Ramathibodi Hospital

Brief 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.

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 Timeline

• Study Start: 2016-09-22
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine	Ephedrine	Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia
NSS	NSS	Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Tympanic temperature	120 minutes	Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups

Secondary Outcome Measures

Name	Time	Method
Shivering	120 minutes	After performing spinal anesthesia in 120 minutes duration
Blood pressure	120 minutes	Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups

Trial Locations

Locations (1)

Department of Anesthesiology, Ramathibodi Hospital; 🇹🇭 Bankok, Bangkok, Thailand