| CTRI Number |
CTRI/2014/10/005151 [Registered on: 29/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
27/10/2014 |
| 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
|
Clonidine as an additive to local anaesthetic injections around scalp. |
|
Scientific Title of Study
|
A prospective, comparative, randomized, double blind study to evaluate the safety and efficacy of scalp block with bupivacaine and clonidine versus bupivacaine only for supratentorial craniotomies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana |
| Designation |
Assistant Professor |
| Affiliation |
King Edward Memorial Hospital. |
| Address |
Department of anaesthesiology,
GSMC and KEM Hospital,
Acharya Dhonde Marg,
Parel
Thane
MAHARASHTRA
400012
India |
| Phone |
9930104106 |
| Fax |
|
| Email |
anjanawajekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjana |
| Designation |
Assistant Professor |
| Affiliation |
King Edward Memorial Hospital. |
| Address |
Department of Anaesthesiology,
GSMC and KEM Hospital,
Acharya Dhonde Marg,
Parel
Thane
MAHARASHTRA
400012
India |
| Phone |
9930104106 |
| Fax |
|
| Email |
anjanawajekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjana |
| Designation |
Assistant Professor |
| Affiliation |
King Edward Memorial Hospital. |
| Address |
Department of Anaesthesiology,
GSMC and KEM Hospital,
Acharya Dhonde Marg,
Parel
Thane
MAHARASHTRA
400012
India |
| Phone |
9930104106 |
| Fax |
|
| Email |
anjanawajekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| King Edward Memorial Hospital,
Acharya Dhonde Marg,Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
King Edward Memorial Hospital |
| Address |
Acharya Dhonde Marg,
Parel 400012 |
| Type of Sponsor |
Government 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 Anjana Wajekar |
GSMC and King Edward Memorial Hospital, Department of anaesthesiology. |
1st floor, KEM Hospital,
Acharya Dhonde Marg
Parel 400012
Mumbai (Suburban)
MAHARASHTRA |
919930104106
anjanawajekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC)I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I and II patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.25% only |
Plain scalp block with 20 ml of 0.25% bupivacaine |
| Intervention |
Clonidine |
Addition of 2mcg/kg clonidine to 20cc of 0.25% bupivacaine in scalp block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1] 60 ASA I and II patients
2] Age 18yrs to 65 yrs
3] Glasgow coma scale 15/15
4] Patients undergoing supratentorial craniotomies under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1] Emergency cases
2] Patients with uncontrolled hypertension
3] Ischaemic heart disease or cardiac arrhythmias
4] Hepatic or renal disease
5] severe pulmonary disease
6] chronic alcoholism and chronic drug abusers
7] History of craniotomy
8] History of drug allergy to local anaesthetics and/or clonidine
9] patients on alpha blockers preoperatively
10] patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative haemodynamics |
Every 5 minutes from skin incision to dura opening and dura closure to skin suturing |
| Intraoperative requirement of fentanyl |
intraoperative |
| Complications like bradycardia, hypertension etc. |
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/05/2014 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary purpose is to study the duration of analgesia and intraoperative haemodynamics after addition of clonidine to scalp block with 0.25% bupivacaine. It is hypothetised that clonidine will prolong the duration of anaesthesia and provide stable intraoperative haemodynamics. |