The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05046054

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.

in minimizing propofol injection pain.

Condition or Disease	Intervention/Treatment	Phase
Transcutaneous Electrical Nerve Stimulation Pain Propofol Adverse Reaction	Device: transcutaneous electrical nerve stimulation Device: Placebo transcutaneous electrical nerve stimulation	N/A

Detailed Description

Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

TENS YW-5000 (YoungWon Medical Co, Korea)TENS YW-5000 (YoungWon Medical Co, Korea)

Masking:

Single (Investigator)

Masking Description:

Two electrodes were attached to the radial side of dominant forearm. In the placebo group the TENS device had no current output although the power "on" indicator light remained active.

Primary Purpose:

Prevention

Official Title:

The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jan 30, 2022

Anticipated Study Completion Date :

Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: transcutaneous electrical nerve stimulation group Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection	Device: transcutaneous electrical nerve stimulation transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
Placebo Comparator: control group No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection	Device: Placebo transcutaneous electrical nerve stimulation Placebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection

Arm

Intervention/Treatment

Active Comparator: transcutaneous electrical nerve stimulation group

Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection

Device: transcutaneous electrical nerve stimulation

transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection

Placebo Comparator: control group

No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection

Device: Placebo transcutaneous electrical nerve stimulation

Placebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection

Outcome Measures

Primary Outcome Measures

pain during propofol injection [15 seconds]
Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Exclusion Criteria:

American Society of Anesthesiologists physical status classification > 3
Patient with a history of allergy to drugs
Patient who takes opioid, sedative, anticonvulsant
Patient with a history of neurologic disease and psychological disorders
patient with skin problem
Patient with pacemaker or electric medical device
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National university hospital	Daegu		Korea, Republic of	41944

Sponsors and Collaborators

Kyungpook National University Hospital

Investigators

Principal Investigator: Younghoon Jeon, Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Younghoon Jeon, Professor, Kyungpook National University Hospital

ClinicalTrials.gov Identifier:

NCT05046054

Other Study ID Numbers:

2021-03-036-001

First Posted:

Sep 16, 2021

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 19, 2022