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

NCT ID: NCT05046054

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-01-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Transcutaneous Electrical Nerve Stimulation Pain Propofol Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TENS YW-5000 (YoungWon Medical Co, Korea)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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transcutaneous electrical nerve stimulation group

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

Group Type ACTIVE_COMPARATOR

transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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

control group

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

Group Type PLACEBO_COMPARATOR

Placebo transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Younghoon Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Younghoon Jeon

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National university hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Younghoon Jeon, Dr

Role: CONTACT

+82534205863

Younghoon Jeon

Role: CONTACT

+82534205863

Facility Contacts

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Younghoon Jeon

Role: primary

+82534205863

Other Identifiers

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2021-03-036-001

Identifier Type: -

Identifier Source: org_study_id

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