- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04943367
Effect of TEAS on Rocuronium Injection Pain
January 5, 2022 updated by: Betul Kozanhan, Konya Meram State Hospital
Efficacy of TEAS On Prevention of Rocuronium Injection Pain
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Konya, Turkey, 42005
- Betul Kozanhan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 year aged
- ASA I-III
- Who was to undergo various elective operations.
Exclusion Criteria:
- Cardiovascular surgery
- Patients with pacemakers
- Patients requiring rapid sequential induction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: GROUP TEAS
Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).
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Transcutaneous electrical acupuncture stimulation
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Placebo Comparator: Control Sham Group
Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.
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Transcutaneous electrical acupuncture stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain with rocuronium injection
Time Frame: 5 minutes
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pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2021
Primary Completion (Actual)
January 5, 2022
Study Completion (Actual)
January 5, 2022
Study Registration Dates
First Submitted
June 18, 2021
First Submitted That Met QC Criteria
June 27, 2021
First Posted (Actual)
June 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 6, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Rocuronium injection pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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