Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper GIT Endoscopy (Valsalva)

Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Injection Site Irritation
• Intervention / Treatment: Other: Valsalva Manoeuvre; Drug: Dexmedetomidine Injection [Precedex]; Drug: normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Najran
    • Sharurah, Najran, Saudi Arabia, 000000
      • Sharurah Armed Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VALSALVA Group; 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.	Other: Valsalva Manoeuvre; Blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds
Experimental: DEXMED Group; 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.	Drug: Dexmedetomidine Injection [Precedex]; The study drugs will be kept at room temperature, preservative-free and will be prepared by an independent anaesthetist into 5 ml of total volume with the addition of 0.9 % normal saline. Tourniquet will be left inflated for 1 minute. Dexmedetomidine mixture and saline will be injected over 5 seconds. After the injection of the drugs, the tourniquet will be released; Other Names: Precedex
Placebo Comparator: CONTROL Group; 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.	Drug: normal Saline; 5 ml saline will be administered.; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	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.	20 seconds after propofol injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal response score	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).	20 seconds after propofol injection
Heart Rate(HR) beat / minute	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	10 minutes
Propofol injection site reaction	the propofol injection site will be checked for signs of inflammation including oedema, pain, wheal, and flare	24 hour
Non-invasive blood pressure(NIBP) mmHg	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.	10 minutes.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2022
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): September 10, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Propofol injection pain; Valsalva Maneuver
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: IRC13412/02/9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No