Clinical trial NCT05225610: Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper GIT Endoscopy
Official title: Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Irritation
Keywords: Propofol injection pain
Dexmedetomidine
Valsalva Maneuver
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 30-60 years old.
2. American Society of Anesthesiologist physical status(ASA) Grade I and II.
3. Upper gastrointestinal Endoscopies.

Exclusion Criteria:

1. Patients with mental illness, restlessness.
2. Cardio-respiratory disease.
3. Chronic pain disorder.
4. Use of preoperative analgesic medication.
5. History of propofol allergy.
6. History of drug abuse.
7. Inability to perform the Valsalva manoeuvre. -

Primary outcomes:
measure: Pain Assessment
timeFrame: 20 seconds after propofol injection.
Secondary outcomes:
measure: Withdrawal response score
timeFrame: 20 seconds after propofol injection
measure: Heart Rate(HR) beat / minute
timeFrame: 10 minutes
measure: Propofol injection site reaction
timeFrame: 24 hour
measure: Non-invasive blood pressure(NIBP) mmHg
timeFrame: 10 minutes.
Other outcomes:
Locations:
city: Sharurah
country: Saudi Arabia
facility: Sharurah Armed Forces Hospital
state: Najran
Study officials:
affiliation: LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
name: AHMED A SHAMA, MD
role: PRINCIPAL_INVESTIGATOR
References: