| CTRI Number |
CTRI/2021/08/035835 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing intravenous Dexmedetomidine and intravenous Dexmedetomidine for attenuation of hemodynamic responses on laryngoscopy, intubation and skull pin application during open brain surgery |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF EFFECTIVENESS OF INTRAVENOUS DEXMEDETOMIDINE VERSUS INTRANASAL DEXMEDETOMIDINE FOR ATTENUATION OF HEMODYNAMIC RESPONSES TO LARYNGOSCOPY,INTUBATION AND FIXATION OF SKULL PIN HOLDER IN PATIENTS UNDERGOING CRANIOTOMY: A RANDOMIZED CONTROLLED DOUBLE-BLIND STUDY |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Singh |
| Designation |
Junior Resident |
| Affiliation |
KGMU |
| Address |
Department of Anaesthesia
Kgmu Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9956886567 |
| Fax |
|
| Email |
garimasinghetw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemlata |
| Designation |
Associate Professor |
| Affiliation |
KGMU |
| Address |
Department of Anaesthesia
Kgmu Lucknow
Department of Anesthesia,
Kgmu Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415410236 |
| Fax |
|
| Email |
hema2211@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Garima Singh |
| Designation |
Junior Resident |
| Affiliation |
KGMU |
| Address |
Department of Anaesthesia
Kgmu Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9956886567 |
| Fax |
|
| Email |
garimasinghetw@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University |
|
|
Primary Sponsor
|
| Name |
King George Mrdical University |
| Address |
Kgmu Lucknow Uttar Pradesh |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Garima |
Kgmu |
Department of Anaesthesia and Department of Neurosurgery
Lucknow
UTTAR PRADESH |
9956886567
garimasinghetw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kgmu institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G96||Other disorders of central nervoussystem, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal dexmedetomidine |
Group 2 will receive intranasal dexmedetomidine 1microgram per kg in undiluted format from parenteral preparation dripped in both nostril in equal volume in supine head down position 10 min before induction. They will also receive normal saline at same rate as in group 1 |
| Intervention |
Intravenous dexmedetomidine |
Group 1 will receive iv dexmedetomidine 0.5 micrograms per kg through infusion over 10 min before induction. They will also receive intranasal dexmedetomidine in same volume as intranasal dexmedetomidine ingroup 2 |
| Comparator Agent |
Not applicable |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient belonging to ASA 1and 2
Patient belongings to age 18 to 70 years
Patient giving informed and written consent |
|
| ExclusionCriteria |
| Details |
Patient with known allergy or hypersensitivity to dexmedetomidine
Patient with history of ischemic heart disease, second or third degree heart block, head injury, uncontrolled hypertension, uncontrolled diabetes, pregnancy,and previous craniotomy incision
Patient with respiratory disease and predicted difficult airway
Patient who refuse to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mean arterial pressure |
Baseline 5 min after, 10 min after after drug administration before laryngosopy and intubation, at 1 min, 3 min, 5 min after intubation,before pin insertion at 1min, 5 min, 10 min,20 min,30 min,60 min afterpin insertion,sedation status at baseline and 10 min after drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare systolic and diastolic blood pressure along with sedation score and adverse effects |
Baseline 5 min after, 10 min after after drug administration before laryngosopy and intubation, at 1 min, 3 min, 5 min after intubation,before pin insertion at 1min, 5 min, 10 min,20 min,30 min,60 min afterpin insertion,sedation status at baseline and 10 min after drug administration |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will compare Intravenous dexmedetomidine with intranasal dexmedetomidine for attenuation of hemodynamic response to laryngoscopy, intubation and fixation of skull pin holder in patient undergoing elective craniotomy |