FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening (FasTrack)

To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.

Study Overview

• Status: Recruiting
• Conditions: Supratentorial Brain Tumor Surgery

Detailed Description

The project will have a total duration of 24 months and will mainly consist of a data collection phase (months 1-24) and a data analysis and results publication phase (months 15-24). Preoperative clinical and socio-demographic data will be collected from patients' medical records. Psychological variables will be administered to the patient before elective neurosurgical surgery.

BIS-guided general anesthesia will be induced by administering sedative and analgesic drugs to the effector site Ce (Effect Site) by target-controlled infusion (TCI). Propofol and remifentanil will be titrated to maintain blood pressure, body temperature, pCO2 and SaO2 in a normal range and BIS values between 40 and 60. Pharmacological data will be relevant at the end of the intervention from the drug infusion pumps. The Recovery Room multidisciplinary team will assess the quality of awakening following the Awakening Chart (Figure 1). This assessment involves dichotomous scoring (yes/no; correct/incorrect) of specific items. To assess the recovery of consciousness, during the pre-extubation phase, simple requests/questions will be asked of the patient: show tongue; show two fingers; give phone number; state place; identify what day is today; report date of birth; notify residence; perform simple multiplication (e.g., 4x5). The following variables will be collected during the periestubation phase: cough, blood pressure ± 20% of baseline, chills, NRS > 3, RASS < -1 or > 0. An abbreviated version of the STAI questionnaire will also be administered to the patient to assess anxiety on awakening. Awakening is considered good and optimal only if a score of 13 is achieved.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Carla Carozzi, M.D.; Phone Number: 2420 +39 02 2394; Email: carla.carozzi@istituto-besta.it
• Study Contact Backup: Name: Marco Gemma, M.D.; Phone Number: 2420 + 39 02 2394; Email: marco.gemma@istituto-besta.it

Study Locations

• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Contact: Carla Carozzi, MD; Phone Number: 2420 + 39 02 2394; Email: carla.carozzi@istituto-besta.it
    • Principal Investigator: Carla Carozzi, MD
    • Sub-Investigator: Marco Gemma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing neurosurgical surgery afferent to the Department of Neurosurgery of the IRCCS Carlo Besta Neurological Institute Foundation will be consecutively enrolled from the date of study approval for 24 months.

Description

Inclusion Criteria:

• Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled:
• Age greater than or equal to 18 years

Exclusion Criteria:

• Psychiatric illness in history and/or taking psychotropic drugs
• Glasgow Coma Score (GCS) < 15
• Presence of overt cognitive decline or speech disorders
• Patients younger than 18 years of age
• Intraoperative hypothermia (< 36°)
• Intraoperative hypotension (MAP < 20% of baseline)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Anaesthesia effect on Awakening	Correlation between intraoperative dosage of Propofol and Remifentanil with respect to dichotomous outcome related to quality of awakening post GA.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RASS Scale score	RASS (Richmond Assesmenet sedation scale) scale score at post-GA awakening Analysis of the association between perioperative indicators - age, BMI, Milan Complexity Score, APAIS - and outcome on awakening. The minimum RASS scale is - 5 (unresponsive patient after painfull stimulation) and the maximum is + 4 (comactive patient). The optimal RASS scale is 0/-1.	2 years
NRS scale score	NRS (Numerical rating scale ) scale score at post-GA awakening Analysis of the association between perioperative indicators - age, BMI, Milan Complexity Score, APAIS - and outcome on awakening. The minimum NRS scale is 0 (no pain at all) and the maximum is 10 (the maximum pain ever suffered)	2 years

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Remifentanil; Pain; Propofol; ERAS; Nociception; BIS; Bispectral Index; NOL; General Anaesthesia; RASS; Craniectomy; Awakening; Fast Track; Neuroanesthesia; Nocipection Level; Target Colled Infusion TCI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: FasTrack

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No