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

M

Mahidol University

Status

Completed

Conditions

Body Temperature Changes

Treatments

Drug: NSS
Drug: Ephedrine

Study type

Interventional

Funder types

Other

Identifiers

NCT02948920
07-59-07
TCTR20161017007 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Ephedrine
Experimental group
Description:
Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia
Treatment:
Drug: Ephedrine
NSS
Placebo Comparator group
Description:
Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia
Treatment:
Drug: NSS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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