CTRI/2020/09/027529RecruitingNot Applicable
tO COMPARE THE EFFECT OF LIGNOCAINE, EPHEDRINE AND COMBINED LIGNOCAINE AND EPHEDRINE PRETREATMENT ON PAIN ON INJECTION DUE TO PROPOFOL IN ADULT PATIENTS UNDERGOING GENERAL ANAESTHESIA - A ONE YEAR HOSPITAL BASED RANDOMIZED CLINICAL TRIAL
Dr Rajesh S Mane1 site in 1 country120 target enrollmentStarted: January 9, 2020Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Pain on injection
Study Overview
Brief Summary
| Propofol is a widely used anaesthetic drug, principally because of its rapid recovery, safety and minimal organ toxicity. Though it is the drug of choice for anaesthetic induction, it has few side effects, of which pain on injection hypotension, bradycardia are noteworthy. Pain from propofol injection occurs in 80% - 90% of patients, if a vein on the dorsum of the hand is used. The etiology of this pain is uncertain, but two causes have been suggested. First, the phenol may cause immediate pain from a local irritant effect on the vein. Second, an indirect action on the endothelium-releasing kininogens may trigger painful stimuli at the nerve endings between the intima and the media of the vessel wall causing delayed pain (after 10-20seconds).Several measures have been taken to alleviate this propofol-induced pain, such as adding lignocaine, cooling, warming or diluting the propofol solution, injection of propofol into a large vein and prior injection of metoclopramide, clonidine, ephedrine, magnesium sulfate, opioids, thiopental, ketamine, paracetamol and flurbiprofen axetil before giving propofol. However, the incidence of pain from propofol is still high. Lignocaine pretreatment is commonly used to decrease propofol-induced pain. The exact mechanism by which it reduces pain on injection of propofol is unknown, but there is a possibility that lignocaine, a local anesthetic, reversibly blocks peripheral nerve pathways through the action on excitable membranes. Propofol can cause hypotension and an initial increase in heart rate (HR) and cardiac output, with a subsequent decrease than the baseline. This effect may be augmented by lignocaine. Ephedrine, an adrenergic agonist, is another drug used to treat pain on propofol injection. It also causes venous dilation and hyperpermeability and increases the contact between the aqueous phase of propofol and free nerve endings. Therefore, ephedrine may reduce the pain caused by propofol injection.Ephedrine has two mechanisms of actions: A direct action through both alpha and beta receptors and an indirect effect by means of releasing endogenous nor-epinephrine. Because of its beta-1 adrenergic stimulating effects, ephedrine is helpful in treating moderate hypotension, particularly if accompanied by bradycardia. It is said that ephedrine may also enhance analgesic effect of lignocaine. In general, a synergistic effect of two agents would allow a reduction in dose for both agents and therefore limit the side effects while improving efficacy. Therefore, co-administration of lignocaine and ephedrine before the induction of anesthesia with propofol may favorably prevent propofol-induced pain and hypotension. To date; no study has been conducted to assess the efficacy of combined ephedrine-lignocaine specifically in reducing the adverse effect on propofol injection. |
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA (American Society of Anaesthesiologists) Grade I and II Age between 18 to 60 years.
- •Patients posted for surgery under General Anaesthesia Informed consent.
Exclusion Criteria
- •History of adverse response to propofol, lignocaine or ephedrine History of allergy, neurologic or cardiovascular disease History of intake of analgesic medication within 24 hours of surgery.
Outcomes
Primary Outcomes
To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Pain on injection
Time Frame: at baseline
In patients receiving propofol for General Anaesthesia.
Time Frame: at baseline
Secondary Outcomes
- To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP) and Heart Rate(HR) In patients receiving propofol for General Anaesthesia.
Investigators
Study Sites (1)
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