| CTRI Number |
CTRI/2019/02/017784 [Registered on: 22/02/2019] Trial Registered Prospectively |
| Last Modified On: |
28/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare decrease in stress response during skull pin insertion between intravenous dexmedetomidine and local infiltration of ropivacaine. |
|
Scientific Title of Study
|
Comparison of intravenous dexmedetomidine with local infiltration of ropivacaine in attenuation of stress response to skull pin insertion in craniotomies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Bala |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma university of health sciences rohtak |
| Address |
PGIMS rohtak, Department of Anaesthesiology.
Rohtak
HARYANA
124001
India |
| Phone |
9416488627 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srishti malhan |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma university of health sciences rohtak |
| Address |
Senior girls hostel pgims rohtak
Department of Anaesthesiology , pgims rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9996888324 |
| Fax |
|
| Email |
drsrishtimalhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti malhan |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma university of health sciences rohtak |
| Address |
Senior girls hostel pgims rohtak
Department of Anaesthesiology , pgims rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9996888324 |
| Fax |
|
| Email |
drsrishtimalhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology. Pt B D sharma institute of medical sciences rohtak |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
PGIMS, UHS rohtak |
| 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 Renu Bala |
PT B D Sharma PGIMS rohtak |
Department of anaesthesiology,
Neurosurgery operation theatre, lala shyam Lal building near trauma centre.
Rohtak
HARYANA |
9416488627
neurodmrenu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, Patients of 18-65 years ASA grade 1 to 3 scheduled to undergo elective craniotomy under general anaesthesia requiring application of head- holder., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomidine before skull pin insertion |
Intravenous dexmedetomidine .75mg/kg/min over 10 minutes before skull pin insertion. |
| Comparator Agent |
Ropivacaine is alocal anaesthetic belonging to amino amide group. |
local infiltration of ropivacaine at skull pin insertion site 2ml each before pin insertion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 to 3 undergoing elective craniotomy under general anaesthesia requiring application of head holder. |
|
| ExclusionCriteria |
| Details |
bradycardia(<50)
second or third degree heart block
uncontrolled hypertention
cardiac, renal or hepatic disease
history of beta blocker intake
glasgow coma scale <13
pitutary disease
known allergic to local anaesthetic or dexmedetomidine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of efficacy of intravenous dexmedetomidine in decreasing skull pin insertion response i.e. alteration in heart rate, mean arterial pressure, BIS, perfusion index,serum cortisol, serum prolactin& blood glucose. |
Vitals are recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion . serum cortisol ,prolactin and blood sugar are measured baseline and 30 minutes after skullpin insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| systolic blood pressure, diastolic blood pressure, end tidal carbon dioxide level, SpO2, Fiso will be noted |
Recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2019 |
| Date of Study Completion (India) |
24/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="27" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present prospective , randomized, comparative, double blind study will be conducted in the Department of Anaesthesiology and Critical Care, PGIMS, rohtak. Written informed and witnessed consent taken for participation. 18-65 years of patients of either sex belonging to ASA grade 2 or 3 undergoing elective craniotomy will be included. The patients will be divided in two groups one will receive intravenous dexmedetomidine other will recei8ve local infiltration of ropivacaine during skullpin insertion. Vitals and other parameters will be recorded at specified time interval. |