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

NCT ID: NCT05225610

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-19
• Study Completion Date: 2022-09-10

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.

Conditions

Injection Site Irritation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Valsalva Manoeuvre

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

5 ml saline will be administered.

Interventions

Valsalva Manoeuvre

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

Intervention Type: OTHER

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

Intervention Type: DRUG

normal Saline

5 ml saline will be administered.

Intervention Type: DRUG

Other Intervention Names

Precedex; saline

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. -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

AHMED ABDELAZIZ SHAMA

LECTURER OF ANESTHESIA AND SURGICAL ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED A SHAMA, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sharurah Armed Forces Hospital

Sharurah, Najran Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IRC13412/02/9

Identifier Type: -

Identifier Source: org_study_id