Vibration Anesthesia for Propofol- Rocuronium Injection Pain

NCT04987866 | Completed

• 1 other identifier: E1-21-1740
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Despite numerous strategies for preventing or alleviating pain associated with propofol and rocuronium injections, it remains common and distressing for patients. Vibration is an effective method of reducing pain during facial cosmetic injections and some venipuncture procedures. But it has not been previously studied in the context of propofol or rocuronium injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on the incidence and severity of propofol and rocuronium injection pain.

Conditions

Vibration; Pain Due to Certain Specified Procedures

Keywords

vibration; analgesia; propofol injection pain; rocuronium injection pain

Outcome Measures

Primary Outcomes (2)

• preventing or reducing propofol injection pain

  Observer rated the pain responses according to a four-point scale. After the injection of propofol to, we also asked the patients whether they had any discomfort.The severity of propofol- injection was evaluated using the following four-point pain response scale developed by McCrirrick and Hunter: level 0: (no pain) no verbal/ facial/ motor reaction to the injection; level 1: (mild pain) a minor verbal/ facial/ motor reaction to the injection but no physical activity or wrist joint movements; and level 2: (moderate pain), pain when asked by the anesthesiologist, or complaint of pain during the injection accompanied by physical activity- facial grimacing or withdrawal of the arm (elbow-shoulder); and level 3: (sever pain), a response accompanied by a facial expression of pain, or a strong vocal response, tears, arm withdrawal, and full body reaction ( including other body movements)

  patients were observed during and after the injection of propofol for 20 seconds by an observer

• preventing or reducing rocuronium injection pain

  The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS). The scale was 0: no movement, 1: movement only the wrist, 2: movement of only the arm (elbow-shoulder) and, 3: general response, movement more than one extremity. 2 minutes after induction, intubation was completed.

  patients were observed during and after the injection of rocuronium for 20 seconds by an observer

Study Arms (2)

group Vibration

EXPERIMENTAL

The participants who were chose an opaque envelope containing yellow paper represented the vibration group (Group V). After 1 min of pre-treatment with the vibration device on the intravenous catheter trace, we manually injected 2-2,5 mg/kg, 1% propofol (Propofol 1%, Fresenius 20 ml flacon, Germany) over 15 s. Observer rated the pain responses according to a four-point scale which developed by McCrirrick and Hunterand. Also asked the patients whether they had any discomfort. After the propofol injection, pain scores were observed during propofol injection and 20 seconds after the injection, and hemodynamic records were taken. 0,6 mg/kg rocuronium (Esmeron® 50 mg.5ml-1 N.V. Organon, Oss, Holland) were injected over 10 seconds. The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS) during and after 20 seconds rocuronium injection.

Device: vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China

group Control

NO INTERVENTION

The participants who were chose an opaque envelope containing red paper represented the group control (Group C).Only propofol and rocuronium were given to these patients. propofol injection made manually 2-2,5 mg/kg, 1% propofol (Propofol 1%, Fresenius 20 ml flacon, Germany) over 15 s. Patients were observed during and after the injection of propofol for 20 seconds. Observer rated the pain responses according to a four-point scale which developed by McCrirrick and Hunter. During the injection of propofol, we also asked the patients whether they had any discomfort. After the propofol injection for 20 seconds, pain scores were observed, and hemodynamic records were taken. 0,6 mg/kg rocuronium (Esmeron® 50 mg.5ml-1 N.V. Organon, Oss, Holland) were injected over 10 seconds. The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS) during and 20 seconds after the rocuronium injection.

Interventions

vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China DEVICE

The vibration device is a reusable, handheld device with a battery-powered motor and a vibration frequency of approximately 6000 times per minute (Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China)

group Vibration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients
• Patients who are planned to undergo gynecology operations

You may not qualify if:

• Participants who were pregnant,
• Patients who had a recent history of a severe allergic or hypersensitivity reaction to propofol or rocuronium

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 3, 2021
• Study Start: May 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)