| CTRI Number |
CTRI/2019/05/019338 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Small craniotomy under awake conditions for large brain lesions |
|
Scientific Title of Study
|
Awake Mini-Craniotomy for Edematous Brain Lesions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jitin Bajaj |
| Designation |
Assistant Professor |
| Affiliation |
NSCB Govt. Medical College, Jabalpur, MP, India |
| Address |
Office, Department of Neurosurgery, NSCB Govt. Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitin Bajaj |
| Designation |
Assistant Professor |
| Affiliation |
NSCB Govt. Medical College, Jabalpur, MP, India |
| Address |
Office, Department of Neurosurgery, NSCB Govt. Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitin Bajaj |
| Designation |
Assistant Professor |
| Affiliation |
NSCB Govt. Medical College, Jabalpur, MP, India |
| Address |
Office, Department of Neurosurgery, NSCB Govt. Medical College, Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8696982911 |
| Fax |
|
| Email |
bajaj.jitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| NSCB Govt Medical College Jabalpur |
|
|
Primary Sponsor
|
| Name |
Dr Jitin Bajaj |
| Address |
Department of Neurosurgery, NSCB Govt Medical College Jabalpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NSCB Govt Medical College |
Office, Department of Neurosurgery, NSCB Govt. Medical College, Jabalpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitin Bajaj |
NSCB Govt Medical College |
Office, Department of Neurosurgery, NSCB Govt. Medical College, Jabalpur
Jabalpur
MADHYA PRADESH |
8696982911
bajaj.jitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Netaji Subhash Chandra Bose Medical College Jabalpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (2) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (3) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, (4) ICD-10 Condition: A171||Meningeal tuberculoma, (5) ICD-10 Condition: C793||Secondary malignant neoplasm of brain and cerebral meninges, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awake minicraniotomy |
A small craniotomy will be done under awake conditions to take out the pathological brain lesions |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult cooperative patients with Supratentorial edematous brain lesions |
|
| ExclusionCriteria |
| Details |
1. Pediatric patients
2. Patient refusal
3. Patients with continuous cough, COPD, cardiac anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of awake minicraniotomy in edematous brain lesions |
Baseline, 1 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the patient comfort during the surgery using pain scores |
Same postoperative day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/05/2019 |
| 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="2"
Months="0"
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
|
Purpose: Introduction: Awake craniotomy has been proven to be safe and effective in several conditions including low grade gliomas, epilepsy surgeries and some vascular conditions.1–3 It provides several advantages over craniotomy in general anesthesia. Firstly, it provides the ability to use intraoperative monitoring of eloquent regions including speech, motor, and visual areas. Secondly, pulmonary complications due to intubation, ventilation etc., that can occur with general anesthesia can be avoided. Thirdly, positional complications like ulcers, spinal torsions etc. can also be prevented. The use of newer drugs like Dexmedetomidine is an alpha-2 adrenergic agonist, have properties of sedative and analgesic effect, reduced delirium and agitation, sympatholysis, cardiovascular stabilizing effect, without respiratory depression and has proved to be safe and effective in perioperative and ICU situations.4 Awake craniotomy has been generally used in non-edematous conditions, possibly due to apprehension of intraoperative brain bulge. If done in edematous conditions, large craniotomies have been advised.5 We have reported minicraniotomy and endoscopic assisted excision of edematous lesions in the past.6 In this article we report the combined use of techniques of awake and minicraniotomy for dealing with edematous brain lesions. References: 1. Gamble AJ, Schaffer SG, Nardi DJ, Chalif DJ, Katz J, Dehdashti AR. Awake Craniotomy in Arteriovenous Malformation Surgery: The Usefulness of Cortical and Subcortical Mapping of Language Function in Selected Patients. World Neurosurg. 2015;84(5):1394-1401. doi:10.1016/j.wneu.2015.06.059 2. Sitnikov AR, Grigoryan YA, Mishnyakova LP. Awake craniotomy without sedation in treatment of patients with lesional epilepsy. Surg Neurol Int. 2018;9:177. doi:10.4103/sni.sni_24_18 3. Taylor MD, Bernstein M. Awake craniotomy with brain mapping as the routine surgical approach to treating patients with supratentorial intraaxial tumors: a prospective trial of 200 cases. J Neurosurg. 1999;90(1):35-41. doi:10.3171/jns.1999.90.1.0035 4. Kaur M, Singh PM. Current role of dexmedetomidine in clinical anesthesia and intensive care. Anesth Essays Res. 2011;5(2):128-133. doi:10.4103/0259-1162.94750 5. Khu KJ, Ng WH. Intraoperative swelling leading to neurological deterioration: an argument for large craniotomy in awake surgery for glioma resection. J Clin Neurosci Off J Neurosurg Soc Australas. 2009;16(7):886-888. doi:10.1016/j.jocn.2008.10.002 6. Ratre S, Yadav YR, Parihar VS, Kher Y. Microendoscopic Removal of Deep-Seated Brain Tumors Using Tubular Retraction System. J Neurol Surg Part Cent Eur Neurosurg. 2016;77(04):312-320. doi:10.1055/s-0036-1580595 |