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

Tanta University

Status: Completed

Conditions: Injection Site Irritation

Treatments: Other: Valsalva Manoeuvre; Drug: normal Saline; Drug: Dexmedetomidine Injection [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT05225610

IRC13412/02/9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

VALSALVA Group

Experimental group

Description:

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.

Treatment:

Other: Valsalva Manoeuvre

DEXMED Group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

CONTROL Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal Saline