| CTRI Number |
CTRI/2018/05/013827 [Registered on: 11/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reduction of pain due to propofol by ondansetron or lignocaine - a comparative study |
|
Scientific Title of Study
|
Comparison of ondansetron or lignocaine pretreatment for reduction in pain due to propofol intravenous injection: Single blind randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvana K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dr.Bhuvana K
Professor and HOD
Department of Pharmacology Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
Kolar
KARNATAKA
563101
India |
| Phone |
9900383738 |
| Fax |
08152243006 |
| Email |
drbhuvanak2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhuvana K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dr.Bhuvana K
Professor and HOD
Department of Pharmacology Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
KARNATAKA
563101
India |
| Phone |
9900383738 |
| Fax |
08152243006 |
| Email |
drbhuvanak2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhuvana K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dr.Bhuvana K
Professor and HOD
Department of Pharmacology Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
KARNATAKA
563101
India |
| Phone |
9900383738 |
| Fax |
08152243006 |
| Email |
drbhuvanak2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka, Kolar, Karnataka, India Pin 563102 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Bhuvana K |
Sri Devaraj Urs Medical College |
Departments of Pharmacology and Anaesthesiology,
RL Jalappa Hospital and Research Centre
Sri Devaraj Urs Academy of Higher Education and Research
Tamaka
Kolar
KARNATAKA |
9900383738
8152243006
drbhuvanak2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education and Research, Kolar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain due to propofol administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine |
Injection 2ml(20mg) of 1% lignocaine intravenously for a period of 10 seconds |
| Intervention |
Ondansetron |
Injection ondansetron 4mg(2ml) intravenously for a period of 10 seconds |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender aged between 21- 50 years
2.Patients with body weight of 50-80 Kg
3.Patients undergoing elective surgeryunder general anesthesia
4.Patients belonging to American Society of Anesthesiology (ASA) physical status I and II
|
|
| ExclusionCriteria |
| Details |
1.History of allergy to study drugs
2.Pregnant and lactating women
3.Patients receiving analgesics 48 hours before surgery
4.Patients with pain posted for elective surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of ondansetron and lignocaine in reducing pain following propofol injection using Verbal Rating Scale (VRS) |
Baseline and 15 seconds after propofol injection intravenoulsy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the adverse effect in both groups using WHO causality assessment and Naranjo probability scales |
Study drugs administration to 6 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="546"
Sample Size from India="546"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/12/2016 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No publications pertaining to this trial - "none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To reduce pain due to propofol injection, various drugs have been tried
such as lignocaine, ketorolac, paracetamol, ketamine, magnesium sulfate or
topical nitroglycerine application but complete attenuation of pain due to
propofol injection was not observed. Mixing lignocaine with
propofol is most commonly used method for prevention of propofol injection pain. Ondansetron is a selective serotonin receptor antagonist (5-HT3),
currently used for the prophylaxis and treatment of postoperative nausea and
vomiting. Some studies have demonstrated that ondansetron can produce local
anesthetic effect, probably by blocking sodium channels. It blocks the
peripheral nociceptive effect of serotonin thus having antinociceptive effect. Ondansetron
binds to the opioid μ receptors and acts as an agonist. Two
comparative studies between lignocaine and ondansetron have been carried out in
India with variable results and they had recruited 40-50 patients.7,8 Routinely ondansetron is administered
preoperatively to prevent post-operative nausea and vomiting. Therefore,
instead of another drug, ondansetron will be compared with lignocaine to assess
the analgesic effect in larger number of individuals. |