Vibration Anesthesia for Propofol- Rocuronium Injection Pain

NCT ID: NCT04987866

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-05-31

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.

Detailed Description

Due to their rapid onset and short duration of action, ease of titration, recovery, and favorable profile for side effects, propofol and rocuronium are agents frequently used together in anesthesia practice and for rapid-sequence intubation. However, both cause severe discomfort due to pain in the injection arm. Some patients recall the induction of anesthesia as the most painful part of the perioperative period.

Vibration anesthesia has repeatedly been shown to alleviate pain sensation effectively and safely. Vibration anesthesia device is designed to reduce the pain from minor procedures, such as injection of medications, suture or staple removal, phlebotomy and even venipuncture pain in pediatric patients. The advantages of this device include its low cost, lack of adverse effects, and ease of use.

It has been shown to reduce pain with a mechanism based on the gate control theory, which states that vibrations stimulate the dorsal horn neurons, the sites at which pain signals are modulated and thus block full transmission of the pain.The investigators therefore proposed this randomized controlled study to compare the effectiveness of a vibration device for propofol and rocuronium injection pain during general anesthesia induction.

Conditions

Vibration; Pain Due to Certain Specified Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group Vibration

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E1-21-1740

Identifier Type: -

Identifier Source: org_study_id