| CTRI Number |
CTRI/2025/08/092510 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Awareness During Brain Surgery Under Anesthesia |
|
Scientific Title of Study
|
Assessment of intraoperative awareness in patients undergoing craniotomy : An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Polepally Divya |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology Programme, 4th Floor, Manipal College of Health Professions,Manipal Academy of Higher Education,Madhavnagar,Manipal,Udupi,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8497957228 |
| Fax |
|
| Email |
polepally.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka G Kini |
| Designation |
Associate Professor and Guide |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology,Kasturba Hospital,Manipal,Udupi,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
Priyanka.kini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Polepally Divya |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology Programme, 4th Floor, Manipal College of Health Professions,Manipal Academy of Higher Education,Madhavnagar,Manipal,Udupi,Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8497957228 |
| Fax |
|
| Email |
polepally.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Medical College,Manipal,Udupi,Karnataka,India,576104 |
|
|
Primary Sponsor
|
| Name |
Polepally divya |
| Address |
Anaesthesia and Operation Theatre Technology Programme,4th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, karnataka,India,576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Priyanka G Kini |
Kasturba Medical College and Hospital |
Operation Theatre Complex,1st Floor,Main OT Block,Manipal,576104,Udupi,Karnataka
Udupi
KARNATAKA |
9845801588
Priyanka.kini@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ASA grading one and two
Glasgow Coma Scale greater than thirteen
Scheduled for craniotomy and excision of elective intracranial space-occupying lesions
|
|
| ExclusionCriteria |
| Details |
Refusal to consent
Participants with poor mental status |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of intraoperative awareness and factors associated with intraoperative awareness |
Intraoperatively and Postoperatively on the day of surgery of 1 hour and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neurosurgical procedures, especially craniotomy patients expose to various intraoperative stimuli and stressors, increase the risk of intraoperative awareness. Factors such as reduced anesthetic doses for cerebral protection, neuromuscular blockade, and hemodynamic fluctuations contribute to this risk. Awareness during surgery can lead to psychological distress, anxiety, and even PTSD. Evaluating its occurrence and contributing factors is essential for identifying high-risk patients, optimizing anesthesia protocols, and implementing better monitoring strategies. By addressing these concerns, this study aims to enhance patient safety, improve anesthetic management, and reduce the incidence of intraoperative awareness, ultimately leading to better neurosurgical outcomes. |