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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02948920

Enrollment

Registered

2016-10-31

Start date

2016-09-22

Completion date

2017-07-27

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes

Keywords

ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering

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)

Interventions

DRUGEphedrine

9 mg of ephedrine (3 ml)

DRUGNSS

3 ml of normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026