Skip to content

Effect of controlled blood pressure reduction on brain oxygen levels in patients undergoing endoscopic pituitary surgeries

Effect of permissive hypotension on cerebral oxygenation and ischemic neurological injury during endoscopic pituitary surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061961
Enrollment
35
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Cerebral Oxygen saturation monitoring: Cerebral oxygen saturation (rSO2) during permissive hypotension will be monitored by Near-infrared spectroscopy (NIRS) using Cerebral oximeter in

Sponsors

GB Pant Institute of Postgraduate Medical Education And Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA I and II patients greater than 18 years of age, scheduled for endoscopic transnasal transsphenoidal pituitary surgery

Exclusion criteria

Exclusion criteria: Patients with: Uncontrolled Hypertension History of obstructive sleep apnea (OSA) Preoperative hemoglobin levels 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

Design outcomes

Primary

MeasureTime frame
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 7100Timepoint: 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

MeasureTime frame
association between Cumulative Saturation below Threshold and change in the serum levels of cerebral ischemia biomarkers from baselineTimepoint: Intraoperative;Association between Cumulative Saturation below Threshold and postoperative cognitive dysfunctionTimepoint: Intraoperative;Association between Decrease in mean arterial pressure and change in cerebral oxygen saturation (rSO2)Timepoint: Intraoperative;Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between patients with normal and impaired cerebral autoregulationTimepoint: Intraoperative;Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between normotensive and controlled hypertensive patientsTimepoint: Intraoperative;Incidence of postoperative cognitive dysfunction : Mini- Mental State examination score (MMSE) and Montreal cognitive assessment (MoCA)Timepoint: Preoperative and Postoperative after 24hours and 72 hours;Postoperative change in serum cerebral ischemia biomarkers levels: NSE, S100 BTimepoint: Preoperative and postoperative;Postoperative change in serum renal and cardiac ischemia biomarker levels: NGAL, hs-cTnTTimepoint: Preoperative and Postopeartive;Severity and duration of cerebral oxygen desaturation: by the Cumulative Saturation below ThresholdTimepoint: Intraoperative

Countries

India

Contacts

Public ContactDr Monica S Tandon

GB Pant Institute of Postgraduate Medical Education And Research

monicastandon@hotmail.com9718599408

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026