NCT04943367

Brief Summary

Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

June 18, 2021

Last Update Submit

January 5, 2022

Conditions

Injection Pain

Outcome Measures

Primary Outcomes (1)

  • Pain with rocuronium injection

    pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium

    5 minutes

Study Arms (2)

GROUP TEAS

ACTIVE COMPARATOR

Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).

Device: TEAS

Control Sham Group

PLACEBO COMPARATOR

Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.

Device: TEAS

Interventions

TEASDEVICE

Transcutaneous electrical acupuncture stimulation

Control Sham GroupGROUP TEAS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year aged
  • ASA I-III
  • Who was to undergo various elective operations.

You may not qualify if:

  • Cardiovascular surgery
  • Patients with pacemakers
  • Patients requiring rapid sequential induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 29, 2021

Study Start

July 12, 2021

Primary Completion

January 5, 2022

Study Completion

January 5, 2022

Last Updated

January 6, 2022

Record last verified: 2022-01

Locations

TU(1)