| CTRI Number |
CTRI/2024/04/066052 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of quality of sleep before surgery on recovery and pain after surgery in patients of brain tumors undergoing surgery electively |
|
Scientific Title of Study
|
Effect of preoperative quality of sleep on postoperative recovery and pain in patients undergoing elective neurosurgery for supratentorial lesions – a prospective 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 |
Dr Stuti Bhamri |
| Designation |
Senior Resident 1st year DM Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanesthesia and Neuro Critical Care,
NIMHANS Campus
Bangalore
KARNATAKA
560029
India |
| Phone |
8095710767 |
| Fax |
|
| Email |
stutibhamri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir V |
| Designation |
Professor |
| Affiliation |
NIMHANS, Bangalore |
| Address |
Department of Neuroanesthesia and Neuro Critical Care,
NIMHANS Campus
Bangalore
KARNATAKA
560029
India |
| Phone |
9900793108 |
| Fax |
|
| Email |
vsudhir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir V |
| Designation |
Professor |
| Affiliation |
NIMHANS, Bangalore |
| Address |
Department of Neuroanesthesia and Neuro Critical Care,
NIMHANS Campus
Bangalore
KARNATAKA
560029
India |
| Phone |
9900793108 |
| Fax |
|
| Email |
vsudhir77@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS)
Hosur Road
Bengaluru - 560011 |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS Bangalore |
| 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 Stuti Bhamri |
National Institute of Mental Health And Neuro Sciences |
NIMHANS Neuro OT Complex,
National Institute of Mental Health And Neuro Sciences (NIMHANS) Campus
Hosur Road
Bangalore - 560011
Bangalore
KARNATAKA |
8095710767
stutibhamri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (3) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (4) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (5) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (6) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (7) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Conscious, alert and oriented patients at the time of assessment undergoing elective neurosurgery for supratentorial lesions. |
|
| ExclusionCriteria |
| Details |
Refusal of consent.
Patients with hearing difficulty, delirious, or with psychiatric disturbances.
Patients planned for post-operative mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the impact of acute and chronic sleep disturbances on post-operative pain in neurosurgical patients
To study the impact of acute and chronic sleep disturbances on post-operative delirium
|
At end of surgery after extubation
at 24 hours post surgery
at 48 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the impact of pre-operative cognition and anxiety on recovery outcome of patients.
To study the quality of sleep 30 days post surgery
|
At end of surgery
At 24 hours post surgery
At 48 hours post surgery
At 30 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="235"
Sample Size from India="235"
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)
|
30/04/2024 |
| 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="2"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is an open label prospective observational study aimed to study the effect of preoperative sleep quality in patinets of brain tumors undergoing elective neurosurgical procedures on post operative recovery outcomes like postoperative delirium and post operative pain relief along with post operative sleep quality thus, affecting recovery profile |