Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study
| Registry | NCT05225610, acronym Valsalva |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 120 (Actual) |
| Sponsor | Tanta University (Other) |
| Conditions | Injection Site Irritation |
| Interventions | Valsalva Manoeuvre, Dexmedetomidine Injection [Precedex], normal Saline (Other, drug) |
| Dates | start 2022-02-19, primary completion 2022-04-15, completion 2022-09-10, first posted 2022-02-04, last updated 2022-10-20 |
| Locations | 1 site in Saudi Arabia |
Related Papers Related Patents Related Grants Related Experts
All trials for Injection Site Irritation All trials of Valsalva Manoeuvre All trials of Dexmedetomidine Injection [Precedex]
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VALSALVA Group | Experimental | Other: Valsalva Manoeuvre | 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. |
| DEXMED Group | Experimental | Drug: Dexmedetomidine Injection [Precedex] | 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. |
| CONTROL Group | Placebo comparator | Drug: normal Saline | 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. |
Sex: All, ages: 30 Years to 60 Years, 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. -
| Facility | City | Country | Status |
|---|---|---|---|
| Sharurah Armed Forces Hospital | Sharurah, Najran Region | Saudi Arabia |