| CTRI Number |
CTRI/2019/08/020826 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
20/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of adding dexmedetomidine to ropivacaine scalp block to attenuate the hemodynamic response to skull pin placement in neurosurgical procedures |
|
Scientific Title of Study
|
To compare efficacy of addition of dexmedetomidine or placebo to ropivacaine scalp block to attenuate the hemodynamic response to skull pin placement in neurosurgical procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahana B N |
| Designation |
Resident In M D Anesthesiology |
| Affiliation |
Sri Venkateshwara Institute Of Medical Science |
| Address |
Department Of Anesthesiology And Critical Care Sri venkateshwara Institute Of Medical Science Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8301027014 |
| Fax |
|
| Email |
drsahana.bn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateshwara Institute Of Medical Science |
| Address |
Department Of Anesthesiology And Critical Care Sri venkateshwara Institute Of Medical Science Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateshwara Institute Of Medical Science |
| Address |
Department Of Anesthesiology And Critical Care Sri venkateshwara Institute Of Medical Science Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical care Sri Venkateshwara Institute Of Medical Science Alipiri road Tirupati Chittoor Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Department Of Anesthesiology and Critical Care |
| Address |
Department Of Anesthesiology And Critical Care Sri venkateshwara Institute Of Medical Science Tirupati |
| 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 |
| Dr Aloka Samantaray |
Sri Venkateshwarw Institute Of medical Sciences |
Alipiri road Tirupathi
Chittoor
ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C71||Malignant neoplasm of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine 1 microgram per kg is added to 25 ml 0.5% ropivacaine and solution is made to 30 ml |
dexmedetomidine 1 microgram per kg is added to 25 ml 0.5% ropivacaine scalp block to attenuate the hemodynamic response to skull pin placement in neuro surgical procedures |
| Comparator Agent |
normal saline is added to 25 ml 0.5% ropivacane and solution is made to 30 ml |
normal saline is added to 25 ml 0.5% ropivacane scalp block to attenuate the hemodynamic response to skull pin placement in neuro surgical procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
Patients aged 18 to 65 years
American Society of Anesthesiologists physical status grade I and II
Patients scheduled for elective neurosurgical procedures under general anesthesia with tracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled hypertension
Patients with preoperative bradycardia, ischemic heart disease, cardiac arrhythmias
Patients with severe hepatic and renal disease
Patients with past history of craniotomy
Patients allergic to study drugs
Patients on alpha blockers treatment preoperatively
Patient refusal
Patient unable to give consent
Pregnant women and lactating mothers
|
|
|
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 , systolic blood pressure , diastolic blood pressure and mean arterial pressure are measured at different time points following skull pin placement . |
Heart rate , systolic blood pressure , diastolic blood pressure and mean arterial pressure are measured at 1 3 5 10 minutes following skull pin placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Number of episodes of hypertension, hypotension, bradycardia and tachycardia |
during study period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
04/11/2019 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a prospective randomised double blind placebo control study In this study 60 patients belonging to ASA physical status grading 1 and 2 will be allocated into two groups each group containing 30 patients In group D patients will be recieving 25ml of 0.5 percent ropivacaine with dexmedetomidine 1 microgram per kg and this solution will be made 30ml In group R patients will be recieving 25 ml of 0.5 percent ropivacaine with normal saline and solution will be made 30 ml Heart rate systolic blood pressure diastolic blood pressure and mean arterial pressure are mnoted before skull pin fixation 1 3 5 and 10 min after skull pin fixation Results will be coded after study |