| CTRI Number |
CTRI/2015/01/005424 [Registered on: 19/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prevention of pain due to propofol (used for induction of anesthesia) injection: A comparative study of lignocaine ( used for local anaesthetic action) and dexmedetomidine ( used to decrease pain of injection) and control group |
|
Scientific Title of Study
|
Prevention of pain due to propofol injection: A comparative study of lignocaine, dexmedetomidine and placebo. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snigdha |
| Designation |
Junior Resident 3 |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800014.
BIHAR (INDIA).
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800014.
BIHAR (INDIA).
Patna
BIHAR
800014
India |
| Phone |
9835399818 |
| Fax |
|
| Email |
dr.snigdha84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar |
| Designation |
Professor and Head of Department of Anesthesia |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800 014.
BIHAR (INDIA).
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800 014.
BIHAR (INDIA).
Patna
BIHAR
800014
India |
| Phone |
9431044957 |
| Fax |
|
| Email |
patnaarun@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Snigdha |
| Designation |
Junior Resident 3 |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800014.
BIHAR (INDIA).
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800 014.
BIHAR (INDIA).
Patna
BIHAR
800014
India |
| Phone |
9717022299 |
| Fax |
|
| Email |
dr.snigdha84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Snigdha |
operation theatre of Indira Gandhi Institute of Medical Sciences,Patna |
Indira Gandhi Institute of Medical Sciences
Sheikhpura,
Patna 800 014.
BIHAR (INDIA)
Patna
BIHAR |
9717022299
dr.snigdha84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I & II undergoing surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedtomidine |
alpha 2 agonist
dose: 0.25microgram /kg injected once over 5 secs intravenously |
| Comparator Agent |
Lignocaine, Normal saline |
local anaesthetic, control
dose is: 0.5microgram/kg over 5 sec given once intravenously |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent.
Patients of either sex.
Aged between 17 -70 years
Belonging to ASA GRADE 1 and 2( Based on the physical status,the patients are classified into categories by American Society of Anaesthesiologists)
Requiring standard General Anaesthesia (G.A)
|
|
| ExclusionCriteria |
| Details |
Concomitant analgesic or sedative medication, patients requiring rapid sequence induction, anticipated difficulty venous access, difficulty in communication
Known sensitivity to lignocaine or dexmedetomidine
Conditions where use of lignocaine and dexmedetomidine may be harmful
Presence of infection on the dorsum of hand
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence and severity of pain due to propofol injection.
Effect of lignocaine, dexmedetomidine and placebo prtreatment in attenuating this pain. |
AT the time of induction of anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the recall of pain in patients after the surgery. |
In the recovery room after the surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims & objectives: this study was designed to compare and evaluate efficacy of lignocaine, dexmedetomidine & placebo in preventing pain due to propofol injection.
Methods: 90 adults were assigned into three groups.With aim of keeping the drug in the vein,forearm was squeezed with tourniquet upto 70 mmhg.Group 1(n=30) received 0.25microgm/kg of dexmedetomidine, group 2(n=30) 0.5 mg/kg of lignocane diluted in 5ml of NS & group 3(n=30) 5ml of NS followed by an injection of proposal from same vein after releasing the occlusion. Pain assessment was made immediately after propofol injection using McCrirrik & Hunter Scale.
Result: the number of patient who suffered from any degree of pain was low in group1 & 2
Discussion: Lidocaine and dexmedetomidine significantly reduced the incidence and severity of propofol injection pain more than placebo ( p< 0.001). The efficacy of dexmedetomidine in alleviating the pain on injection of propofol is no different from lidocaine.
Conclusion: Dexmedetomidine pretreatment may be used to reduce the incidence of pain on injection of propofol, with added advantage of sparing effect on the requirement of analgesics and sedatives, better hemodynamics profile and anti- shivering action |