NCT02948920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

October 27, 2016

Last Update Submit

October 5, 2018

Conditions

Body Temperature Changes

Keywords

ephedrinecore temperaturetympanic temperatureheat lossspinal anesthesianeuraxialhypothermiashivering

Outcome Measures

Primary Outcomes (1)

  • Tympanic temperature

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

    120 minutes

Secondary Outcomes (2)

  • Blood pressure

    120 minutes

  • Shivering

    120 minutes

Study Arms (2)

Ephedrine

EXPERIMENTAL

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

Drug: Ephedrine

NSS

PLACEBO COMPARATOR

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

Drug: NSS

Interventions

EphedrineDRUG

9 mg of ephedrine (3 ml)

Also known as: Experimental
Ephedrine
NSSDRUG

3 ml of normal saline

Also known as: Control
NSS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Body Temperature ChangesHypothermia

Interventions

Ephedrine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Thanist Pravitharangul, MD

    Department of Anesthesiology, Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 27, 2016

First Posted

October 31, 2016

Study Start

September 22, 2016

Primary Completion

July 27, 2017

Study Completion

July 27, 2017

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)