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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

Primary Purpose

Body Temperature Changes

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Ephedrine

NSS

About this trial

This is an interventional prevention trial for Body Temperature Changes focused on measuring ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Anesthesiology, Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ephedrine

NSS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tympanic temperature

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

Secondary Outcome Measures

Blood pressure

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

Shivering

After performing spinal anesthesia in 120 minutes duration

Full Information

NCT ID

NCT02948920

First Posted

October 27, 2016

Last Updated

October 5, 2018

Sponsor

Ramathibodi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02948920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 22, 2016 (Actual)

Primary Completion Date

July 27, 2017 (Actual)

Study Completion Date

July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ramathibodi Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Temperature Changes

Keywords

ephedrine, core temperature, tympanic temperature, heat loss, spinal anesthesia, neuraxial, hypothermia, shivering

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ephedrine

Arm Type

Experimental

Arm Description

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

Arm Title

NSS

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ephedrine

Other Intervention Name(s)

Experimental

Intervention Description

9 mg of ephedrine (3 ml)

Intervention Type

Drug

Intervention Name(s)

NSS

Other Intervention Name(s)

Control

Intervention Description

3 ml of normal saline

Primary Outcome Measure Information:

Title

Tympanic temperature

Description

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

Time Frame

120 minutes

Secondary Outcome Measure Information:

Title

Blood pressure

Description

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

Time Frame

120 minutes

Title

Shivering

Description

After performing spinal anesthesia in 120 minutes duration

Time Frame

120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thanist Pravitharangul, MD

Organizational Affiliation

Department of Anesthesiology, Ramathibodi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology, Ramathibodi Hospital

City

Bankok

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

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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

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