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

Study Overview
=================
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)

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

Conditions
-----------------
Body Temperature Changes

Intervention / Treatment
-----------------
* Drug: Ephedrine
* Drug: NSS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ephedrine<br>Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia | Drug: Ephedrine<br>* 9 mg of ephedrine (3 ml)<br>* Other names: Experimental;|
| Placebo Comparator: NSS<br>Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia | Drug: NSS<br>* 3 ml of normal saline<br>* Other names: Control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanic temperature | 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 | Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups | 120 minutes | 
| Shivering | After performing spinal anesthesia in 120 minutes duration | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering