| CTRI Number |
CTRI/2017/11/010628 [Registered on: 24/11/2017] Trial Registered Prospectively |
| Last Modified On: |
23/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of three drugs- Ondansetron, Lidocaine and Dexamethasone in relieving pain caused by injection of Propofol during induction of sleep during general anaesthesia. |
|
Scientific Title of Study
|
Prevention of Propofol injection pain:A comparison between Ondansetron,Dexamethasone and Lidocaine. |
| Trial Acronym |
PLOD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arpana Kedlaya |
| Designation |
Assistant Professor |
| Affiliation |
St JOHNS MEDICAL COLLEGE HOSPITAL. |
| Address |
Department of Anesthesiology, St Johns Medical College Hospital, Bnagalore-560034.
Department of Anesthesiology, St Johns Medical College Hospital, Bnagalore-560034.
Bangalore
KARNATAKA
560034
India |
| Phone |
9945346123 |
| Fax |
|
| Email |
drarpanak@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpana Kedlaya |
| Designation |
Assistant Professor |
| Affiliation |
ST JOHNS MEDICAL COLLEGE HOSPITAL. |
| Address |
Department of Anesthesiology, St Johns Medical College Hospital. Bangalore.
Department of Anesthesiology, St Johns Medical College Hospital. Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9945346123 |
| Fax |
|
| Email |
drarpanak@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpana Kedlaya |
| Designation |
Assistant Professor |
| Affiliation |
St JOHNS MEDICAL COLLEGE HOSPITAL. |
| Address |
Department of Anesthesiology, St Johns Medical College Hospital. Bangalore.
Department of Anesthesiology, St Johns Medical College Hospital. Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9945346123 |
| Fax |
|
| Email |
drarpanak@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, St Johns Medical College Hospital, Bangalore-560034. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology St johns medical college hospital Bangalore |
| Address |
Department of Anesthesiology, St johns medical college hospital. Bangalore. |
| 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 |
| DR Arpana Kedlaya |
st jOHNS MEDICAL COLLEGE HOSPITAL, BANGALORE |
Department of Anesthesiology, St johns medical college hospital. Bangalore.
Bangalore
KARNATAKA |
9945346123
drarpanak@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICALCOMMITTEE,STJOHNSMEDICALCOLLEGEHOSPITAL,BANGALORE-560034 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
COMING FOR ELECTIVE SURGERY UNDER GENERAL ANESTHESIA WITH NO HYPERTENSION/DIABETES MELLITES, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection ondansetron 4mg intraveously
Injection lidocaine 40mg intravenously
Injection dexamethasone 6mg intravenously. |
Drugs administered intravenously as single dose just before administering Injection propofol. |
| Intervention |
injection ondansetron 4mg, injection Lidocaine 40mg or Injection Dexamethasone 6mg. |
pretreatment with injection ondansetron 4mg, injection Lidocaine 40mg or Injection Dexamethasone 6mg administered intravenously before administration of injection propofol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group 18-59 yrs
2. American society of anaesthesiology (ASA) physical status I and II.
3. All general surgical procedures .
|
|
| ExclusionCriteria |
| Details |
1. Patients with allergy to propofol, lignocaine.
2. Patients with anticipated difficult airway
3. Patients with cardiac conduction defects, congenital heart diseases
4. Haemodynamic instability
5. Patients with chronic pain syndromes.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of pre-treatment with lidocaine, ondansetron or dexamethasone in reducing the pain of propofol injection in adult patients scheduled for surgical procedures under general anaesthesia.
|
assessment of pain scoring 15 seconds after administering propofol
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess any reaction to the drug at injection site. |
at the end of general surgical procedure approximately 60-90 minutes. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/12/2017 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised double,blinded parallel group, single centre trial comparing the efficacy of pretreatment Ondansetron 4mg ,Lidocaine 40mg or Dexamethasone 6mg Administered intravenously, in alleviating the pain caused by administration of injection Propofol during induction of general anesthesia in adult patients scheduled for routine surgical procedures.The secondary objective is to assess any reaction to the drugs at the injection site at the end of the surgical procedures. .
|