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

Sponsor

Ramathibodi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02948920

Collaborator

(none)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Temperature Changes	Drug: Ephedrine Drug: NSS	N/A

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

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 22, 2016

Actual Primary Completion Date :

Jul 27, 2017

Actual Study Completion Date :

Jul 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ephedrine Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia	Drug: Ephedrine 9 mg of ephedrine (3 ml) Other Names: Experimental
Placebo Comparator: NSS Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia	Drug: NSS 3 ml of normal saline Other Names: Control

Arm

Intervention/Treatment

Experimental: Ephedrine

Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia

Drug: Ephedrine

9 mg of ephedrine (3 ml)

Other Names:

Experimental

Placebo Comparator: NSS

Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia

Drug: NSS

3 ml of normal saline

Other Names:

Control

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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