| CTRI Number |
CTRI/2024/01/061961 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of controlled blood pressure reduction on brain oxygen levels in patients undergoing endoscopic pituitary surgeries |
|
Scientific Title of Study
|
Effect of permissive hypotension on cerebral oxygenation and ischemic neurological injury during endoscopic pituitary surgeries |
| 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 Madhuri Garg |
| Designation |
Senior Resident, DM Neuroanesthesia |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education And Research |
| Address |
Neuroanesthesia Unit, Department of Anesthesia and Intensive Care,Room no-630, Anesthesia Office,6th Floor, Academic Block, GB Pant Institute of Postgraduate Medical Education And Research, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9643410182 |
| Fax |
|
| Email |
dr.madhurigarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director Professor and Head of Department |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education And Research |
| Address |
Department of Anesthesia and Intensive Care, Room no-619,6th Floor, Academic Block, GB Pant Institute of Postgraduate Medical Education And Research, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director Professor and Head of Department |
| Affiliation |
GB Pant Institute of Postgraduate Medical Education And Research |
| Address |
Department of Anesthesia and Intensive Care, Room no-619, 6th Floor, Academic Block, GB Pant Institute of Postgraduate Medical Education And Research, New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GB Pant Institute of Postgraduate Medical Education And Research, New delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
GB Pant Institute of Postgraduate Medical Education And Research |
| Address |
Department of Anesthesia and Intensive Care, 6th floor, Academic Block, GB pant Hospital, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Madhuri Garg |
GB pant Hospital |
Neuro OT, 2nd Floor, A block
New Delhi
DELHI |
9643410182
dr.madhurigarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cerebral Oxygen saturation monitoring |
Cerebral oxygen saturation (rSO2) during permissive hypotension will be monitored by Near-infrared spectroscopy (NIRS) using Cerebral oximeter in patients undergoing endoscopic pituitary surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA I and II patients greater than 18 years of age, scheduled for endoscopic transnasal transsphenoidal pituitary surgery |
|
| ExclusionCriteria |
| Details |
Patients with:
Uncontrolled Hypertension
History of obstructive sleep apnea (OSA)
Preoperative hemoglobin levels <10 gm/dl
Preoperative MMSE score ≤23
Preoperative MoCA score ≤25
History of cerebrovascular disease
History of documented carotid artery disease
History of anxiety and psychiatric illness
History of ischemic heart disease, cardiac rhythm disturbances, intracardiac shunts.
Renal or hepatic dysfunction
Anticipated difficult airway
History of allergy or drug sensitivity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of cerebral desaturation events determined by number of patients who experience a decrease in rSO2 values to less than 80% of their baseline value or an absolute value less than 55% for more than 15 seconds, assessed with a non-invasive cerebral oximeter INVOSTM 7100 |
Cerebral oxygenation (rSO2) will be continuously monitored intraoperatively.
Every episode of CDE will be recorded.
Parameters recorded during CDE-
1) rSO2
2) Hemodynamic parameters
3) Duration of CDE
4) Postintervention rSO2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity and duration of cerebral oxygen desaturation: by the Cumulative Saturation below Threshold |
Intraoperative |
| Incidence of postoperative cognitive dysfunction : Mini- Mental State examination score (MMSE) and Montreal cognitive assessment (MoCA) |
Preoperative and Postoperative after 24hours and 72 hours |
| Postoperative change in serum cerebral ischemia biomarkers levels: NSE, S100 B |
Preoperative and postoperative |
| Postoperative change in serum renal and cardiac ischemia biomarker levels: NGAL, hs-cTnT |
Preoperative and Postopeartive |
| Association between Decrease in mean arterial pressure and change in cerebral oxygen saturation (rSO2) |
Intraoperative |
| Association between Cumulative Saturation below Threshold and postoperative cognitive dysfunction |
Intraoperative |
| association between Cumulative Saturation below Threshold and change in the serum levels of cerebral ischemia biomarkers from baseline |
Intraoperative |
| Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between normotensive and controlled hypertensive patients |
Intraoperative |
| Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between patients with normal and impaired cerebral autoregulation |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/02/2024 |
| 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="1"
Months="6"
Days="0" |
|
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
|
Permissive Hypotension (PH) is considered to be an essential prerequisite for obtaining a satisfcatory oligemic surgical field during prolonged endoscopic surgeries. Deliberate lowering of blood pressure to below normal, introduces a risk of cerebral hypoperfusion, decreased cerebral oxygenation and ischemic neuronal damage which can result in adverese neurological events such as postoperative cognitive impairment, neurological deficits, stroke, coma and even death. Presently there is a knowledge gap about the magnitude of the impact of controlled moderate permissive hypotension on cerebral oxygenation in patients undergoing these surgeries. LACUNAE: To the best of our knowledge, no previous study has assessed the safety of PH in patients undergoing endoscopic pituitary surgeries. Hence in this prospective observational study, we aim to investigate the potential impact of intraoperative PH on cerebral oxygenation, and ischemic neurological injury in this patient population We will assess cerebral oxygenation intraoperatively during permissive hypotension with near infrared spectroscopy (NIRS) based cerebral oximetry. Ischemic neurological injury will be assessed clinically by detection of postoperative cognitive dysfunction using MMSE and MoCA scores. Serological markers of cerbral ischemia (NSE, S100B), and early predictors of acute and cardiac and kidney inury (hs-cTnT, NGAL) will also be assessed pre and postoperatively to determine the impact on vital organs. |