| CTRI Number |
CTRI/2012/04/002595 [Registered on: 24/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between IV dexmedetomidine (to reduce pain and increase in heart rate, blood pressure) and local lignocaine infiltration to reduce hemodynamic response (increase in heart rate,blood pressure) to skull pin application (to stabilize head) during neurosurgery |
|
Scientific Title of Study
|
Comparison between intravenous dexmedetomidine and lignocaine infiltration to attenuate the haemodynamic response to skull pin head-holder application during craniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANU PAUL |
| Designation |
RESIDENT ANESTHESIOLOGIST |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9535619396 |
| Fax |
|
| Email |
anupaul84@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
KRISHNA H M |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448983314 |
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNA H M |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448983314 |
| Fax |
|
| Email |
hmkrishna20032002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KASTURBA HOSPITAL KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
KASTURBA MEDICAL COLLEGE, MANIPAL 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| KRISHNA H M |
KASTURBA HOSPITAL, MANIPAL |
KASTURBA HOSPITAL MANIPAL, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA |
9448983314
hmkrishna20032002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA HOSPITAL, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AGED BETWEEN 18-70 YEARS, BELONGING TO AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS 1 AND 2, SCHEDULED FOR ELECTIVE CRANIOTOMY UNDER GENERAL ANESTHESIA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRAVENOUS DEXMEDETOMIDINE |
IV DEXMEDETOMIDINE 1mcg/kg is given as infusion over 10 minutes soon after recording the baseline hemodynamic parameters in the operating room |
| Comparator Agent |
Local infiltration of 2% lignocaine |
2% lignocaine is locally infiltrated at the pin application sites in the skull - 3 ml for each site of pin application, just before pin application (patient is under general anesthesia) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective craniotomy in supine or lateral position under general anaesthesia.
2. American Society of Anesthesiologists Physical Status (ASAPS) 1or 2
3. Age between 18 to 70 years
|
|
| ExclusionCriteria |
| Details |
1. Hypertension
2. Ischaemic heart disease
3. 2nd or 3rd degree heart block
4. Pregnancy or lactation
5. Signs and symptoms of raised intracranial pressure
6. Head injury
7. Previous craniotomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEART RATE (less than 40 beats per minute and 30% increase)AND MEAN ARTERIAL PRESSURE (30% change) RESPONSE TO SKULL PIN APPLICATION |
1, 2, 3, 4, 5, 10 AND 15 minutes after pin application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| entropy values |
1,2,3,4,5,10,15 minutes after pin application |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2011 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this patient investigator blinded trial 50 patients aged 18-70 years scheduled for elective craniptomy will be recruited. The objective of the study is to find out whether intravenous dexmedetomidine 1 mcg/kg given over 10 minutes or local infiltration of 2% lignocaine (3ml per pin site) is a better agent in obtunding the hemodynamic response to skull pin application. Heart rate and mean arterial pressure will be recorded and compared between the groups (apart from baseline) at 1,2,3,4,5,10 and 15 minutes following pin application. Heart rate less than 40/minute, increase by 30%, change in mean arterial pressure by 30% will be regarded as significant. Entropy values at corresponding time intervals will be recorded. |