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Completed

NCT Number: NCT02948920

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

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.

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Key information

Conditions

Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine

Drug

9 mg of ephedrine (3 ml)

Other names: Experimental

NSS

Drug

3 ml of normal saline

Other names: Control

Primary outcomes

  1. Tympanic temperature

    Time frame: 120 minutes

    Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups

Secondary outcomes

  1. Blood pressure

    Time frame: 120 minutes

    Difference of changes of blood pressure at time points compare with baseline (before spinal block) between two groups

  2. Shivering

    Time frame: 120 minutes

    After performing spinal anesthesia in 120 minutes duration

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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