Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper GIT Endoscopy
- Conditions
- Injection Site Irritation
- Interventions
- Registration Number
- NCT05225610
- Lead Sponsor
- Tanta University
- Brief Summary
No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.
- Detailed Description
Propofol is a commonly used anaesthetic for inducing general anaesthesia. Pain on propofol injection is distressing and is one of the limitations of its use. Propofol is a phenol compound, which irritates nerve endings on the venous endothelium to produce immediate pain, whereas delayed pain is mediated by the release of bradykinin. Bradykinin causes vasodilation and increases venous permeability, thereby facilitating contact of the aqueous phase of propofol with nerve endings. Delayed pain occurs 10-20 seconds after injection.
Various methods have been tried so far to reduce pain on propofol injection. A commonly used technique is lignocaine either as pre-treatment or mixed with propofol. Other methods include the use of butorphanol, ondansetron, metoclopramide, opioid, or thiopentone. Propofol injection into a large vein, pre-injection cooling, or warming of propofol have also been investigated.
The Valsalva manoeuvre is a physiological technique, used in the reduction of pain associated with several procedures. The Valsalva manoeuvre alleviates both the somatic and psychological aspects of painful procedures.
Dexmedetomidine is an alpha-2 adrenoceptor agonist that has analgesic and sedative properties, it has been evaluated for reducing the incidence and intensity of propofol-induced pain, but reported results are inconsistent.
in this study, investigators will study the effect of Valsalva manoeuvre as compared with dexmedetomidine injection in reducing the pain associated with propofol injection in upper gastrointestinal endoscopies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Adult patients aged 30-60 years old.
- American Society of Anesthesiologist physical status(ASA) Grade I and II.
- Upper gastrointestinal Endoscopies.
- Patients with mental illness, restlessness.
- Cardio-respiratory disease.
- Chronic pain disorder.
- Use of preoperative analgesic medication.
- History of propofol allergy.
- History of drug abuse.
- Inability to perform the Valsalva manoeuvre. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VALSALVA Group Valsalva Manoeuvre 40 Patients will perform the Valsalva manoeuvre before starting propofol injection by blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds and 5 ml saline will be administered in 5 seconds. CONTROL Group normal Saline 40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group and only 5 ml saline will be administered over 5 seconds. DEXMED Group Dexmedetomidine Injection [Precedex] 40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group, patients will receive 0.5 µg/kg Dexmedetomidine diluted in 5 ml saline in 5 seconds as a sedating dose prior to injection of propofol.
- Primary Outcome Measures
Name Time Method Pain Assessment 20 seconds after propofol injection. using a ruler as the visual analogue scale(VAS), The VAS score ranged from 0-10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will be instructed to mark a point on the VAS ruler that represented the intensity of pain. The pain score was determined by measuring the distance in mm between 0 (no pain) and the mark will be indicated by the patient on the ruler.
- Secondary Outcome Measures
Name Time Method Propofol injection site reaction 24 hour the propofol injection site will be checked for signs of inflammation including oedema, pain, wheal, and flare
Withdrawal response score 20 seconds after propofol injection withdrawal response will be assessed using standard questions including comfort during injection, verbal response, and behavioural signs (facial grimacing, arm withdrawal, or tears). the withdrawal response scoring will be graded on a 4-point scale: 0 = no pain, 1 = mild pain (pain reported only in response to questioning without any behavioural signs), 2 = moderate pain (pain reported in response to questioning and accompanied by behavioural signs or pain reported spontaneously without questioning), and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).
Heart Rate(HR) beat / minute 10 minutes the heart rate (HR) will be recorded before the Valsalva manoeuvre, at 1 minute, at 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on
Non-invasive blood pressure(NIBP) mmHg 10 minutes. Non-invasive blood pressure(NIBP) will be recorded before the Valsalva manoeuvre, at 1 minute, 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on.
Trial Locations
- Locations (1)
Sharurah Armed Forces Hospital
🇸🇦Sharurah, Najran, Saudi Arabia