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

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

Sponsors

Lead Sponsor: Ramathibodi Hospital

Source Ramathibodi Hospital
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)

Overall Status Completed
Start Date September 22, 2016
Completion Date July 27, 2017
Primary Completion Date July 27, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Tympanic temperature 120 minutes
Secondary Outcome
Measure Time Frame
Blood pressure 120 minutes
Shivering 120 minutes
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ephedrine

Description: 9 mg of ephedrine (3 ml)

Arm Group Label: Ephedrine

Other Name: Experimental

Intervention Type: Drug

Intervention Name: NSS

Description: 3 ml of normal saline

Arm Group Label: NSS

Other Name: Control

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thanist Pravitharangul, MD Principal Investigator Department of Anesthesiology, Ramathibodi Hospital
Location
Facility: Department of Anesthesiology, Ramathibodi Hospital
Location Countries

Thailand

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ramathibodi Hospital

Investigator Full Name: Thanist Pravitharangul

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ephedrine

Type: Experimental

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

Label: NSS

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov