| CTRI Number |
CTRI/2020/09/027529 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two drugs namely, lignocaine and ephedrine and their combination for pretreatment on pain on injection due to propofol in adult patients undergoing general anaesthesia for elective surgeries |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1256-5515 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sanjeev Adhyapak |
| Designation |
Post Graduate, |
| Affiliation |
J N Medical College Belagavi |
| Address |
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar Belgaum KARNATAKA 590010 India |
| Phone |
09483272179 |
| Fax |
|
| Email |
nadhya94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrRajesh S Mane |
| Designation |
Professor and HOD of Department of Anaesthesiology |
| Affiliation |
J. N. Medical College, Belagavi |
| Address |
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Charitable Hospital and MRC Nehru Nagar, Belagavi Belgaum KARNATAKA 590010 India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrRajesh S Mane |
| Designation |
Professor and HOD of Department of Anaesthesiology |
| Affiliation |
J. N. Medical College, Belagavi |
| Address |
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Charitable Hospital and MRC Nehru Nagar, Belagavi Belgaum KARNATAKA 590010 India |
| Phone |
9844131062 |
| Fax |
|
| Email |
drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajesh Mane
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Charitable Hospital and MRC
Nehru Nagar,
Belagavi, Karnataka-590010 |
|
|
Primary Sponsor
|
| Name |
Dr Rajesh S Mane |
| Address |
Department of Anaesthesiology
KLEs Dr Prabhakar Kore Charitable Hospital and MRC
Belagavi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNeha Adhyapak |
Department of Anaesthesiology |
KLEs Dr. Prabhakar Kore Charitable Hospital and MRC
Nehru Nagar Belgaum KARNATAKA |
09483272179
nadhya94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee on Human Subjects and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injecting multiple i.v drugs prior to injection of i.v propofol |
The drugs used to do so are, i.
v Lignocaine, i.v ephedrine and combined i.v lignocaine and ephedrine.
Group A: Intravenous lignocaine(0.5 mg/kg) alone
Group B: Intravenous ephedrine
(70μ/kg)alone
Group C: Intravenous lignocaine
(0.5 mg/kg) + ephedrine (30 μ/kg)
|
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anaesthesiologists) Grade I and II
Age between 18 to 60 years.
Patients posted for surgery under General Anaesthesia
Informed consent.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Pain on injection
In patients receiving propofol for General Anaesthesia.
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
at baseline |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. | |