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

October 5, 2018 updated by: Thanist Pravitharangul, Ramathibodi Hospital
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bangkok
      • Bankok, Bangkok, Thailand, 10400
        • Department of Anesthesiology, Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thanist Pravitharangul, MD, Department of Anesthesiology, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Thanist Pravitharangul, Wirakorn Koopinpaitoon, Rungruedee Kraisen, Rojnarin Komonhirun. Ephedrine and propofol for induction of general anesthesia can decrease intraoperative hypothermia in patients undergoing plastic and breast surgery: a randomized, controlled trial. Asian Biomedicine Vol. 9 No. 3 June 2015; 379 - 385

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2016

Primary Completion (Actual)

July 27, 2017

Study Completion (Actual)

July 27, 2017

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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