Clinical trial NCT04987866: Vibration Anesthesia for Propofol- Rocuronium Injection Pain
Official title: Vibration Anesthesia for Propofol- Rocuronium Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vibration
Pain Due to Certain Specified Procedures
Keywords: vibration
analgesia
propofol injection pain
rocuronium injection pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: preventing or reducing propofol injection pain
timeFrame: patients were observed during and after the injection of propofol for 20 seconds by an observer
measure: preventing or reducing rocuronium injection pain
timeFrame: patients were observed during and after the injection of rocuronium for 20 seconds by an observer
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: