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

NCT05225610 | Completed DMC

• 1 other identifier: IRC13412/02/9
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site Irritation

Keywords

Propofol injection pain; Dexmedetomidine; Valsalva Maneuver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Withdrawal response score

  20 seconds after propofol injection

• Heart Rate(HR) beat / minute

  10 minutes

• Propofol injection site reaction

  24 hour

• Non-invasive blood pressure(NIBP) mmHg

  10 minutes.

Study Arms (3)

VALSALVA Group

EXPERIMENTAL

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

DEXMED Group

EXPERIMENTAL

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]

CONTROL Group

PLACEBO COMPARATOR

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

Interventions

Valsalva Manoeuvre OTHER

Blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds

VALSALVA Group

Dexmedetomidine Injection [Precedex] DRUG

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

Also known as: Precedex

DEXMED Group

normal Saline DRUG

5 ml saline will be administered.

Also known as: saline

CONTROL Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Sharurah Armed Forces Hospital

Sharurah, Najran Region, 000000, Saudi Arabia

Location

MeSH Terms

Interventions

Valsalva Maneuver; Dexmedetomidine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• AHMED A SHAMA, MD

  LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICAL ICU

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 4, 2022
• Study Start: February 19, 2022
• Primary Completion: April 15, 2022
• Study Completion: September 10, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)