Assessment of brain oxygenation in three clinical situations

Phase 1

• Conditions: Patients undergoing neurosurgery; MedDRA version: 20.0Level: LLTClassification code 10053764Term: Brain tumor operationSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002776-83-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-07
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adult patients (=18 years) scheduled for elective skull base craniotomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients undergoing re-operation, patients with pre-operative hypotension (defined as sBP < 100 mmHg), patients with pre-operative hypoxia (SpO2 < 90% without oxygen supplementation before surgery); no negative pregnancy test for women <50 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of cerebral oxygenation under three clinically relevant conditions;Secondary Objective: Assessment of cerebral oxygenation under three clinically relevant conditions;Primary end point(s): Changes in cerebral oxygenation;Timepoint(s) of evaluation of this end point: During anaesthesia

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cerebral oxygenation with non-licox measurements;Timepoint(s) of evaluation of this end point: During anaesthesia