| CTRI Number |
CTRI/2008/091/000027 [Registered on: 07/05/2008] |
| Last Modified On: |
19/04/2011 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
To determine the effect of instillation of lignocaine down the endotracheal tube in attenuating airway and circulatory response to extubation |
Scientific Title of Study
Modification(s)
|
Instillation of lignocaine down the endotracheal tube to attenuate extubation response |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smitha Elizabeth George |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesia,C.M.C.H, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2282105 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.comsmitha_george@cmcvellore.ac.in,smithakottarathil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Grace Korula |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesia,C.M.C.H, Vellore.
Vellore
TAMIL NADU
India |
| Phone |
0416-2282105 |
| Fax |
|
| Email |
gracekorula@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smitha Elizabeth George, Georgene Singh |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesia,C.M.C.H, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2282105 |
| Fax |
|
| Email |
smitha_george@cmcvellore.ac.in,georgenesikka@gmail.com. |
|
|
Source of Monetary or Material Support
|
| Christian Medical College & Hospital, Vellore,Fluid Research Grant. |
|
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Primary Sponsor
|
| Name |
Christian Medical College & Hospital, Vellore. |
| Address |
|
| Type of Sponsor |
|
|
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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 Smitha Elizabeth George |
Department of Anaesthesia, CMCH, vellore. |
CMCH,-
Vellore
TAMIL NADU |
0416-2282105
smithakottarathil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CMCH Vellore Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Extubation response in neurosurgical patients and the effects of lignocaine in attenuating extubation response., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lignocaine |
dose 1mg/kg intravenously or through the endotracheal tube at the end of surgery. |
| Comparator Agent |
normal saline |
|
| Comparator Agent |
normal saline 0.9% |
at dose of 1ml for every 20 kgbody weight of the patient,at the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Patients undergoing craniotomies with GCS 15/15.
Age 18-65 years inclusive.
ASA grade 1 & 2.(American Society of Anaesthesiologists grade) |
|
| ExclusionCriteria |
| Details |
Patients with
1.Sore throat/Active U.R.I
2.Requirement for postop ventilation.
3.History of laryngeal/ tracheal pathology/ surgery.
4.History of asthma/ COPD. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cough at extubation |
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| hemodynamics at extubation, time taken for extubation, post op sore throat. |
|
| plasma levels of lignocaine |
at extubation and at 10 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India=""
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
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
04/03/2008 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/03/2008 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group trial which will be done in 114 patients undergoing craniotomies with skull pins to evaluate the efficacy of lignocaine in attenuating airway and circulatory response to extubation when administered through the endotracheal tube.This study will be done in the department of anaesthesia in CMCH,Vellore,Tamil Nadu .The primary outcome will be cough at extubation. The secondary outcome will be hemodynamics at extubation, time taken for extubation and post operative sore throat and plasma levels of lignocaine at extubation. |