FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Supratentorial Brain Tumor Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical 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.
Primary outcome measures
- General Anaesthesia effect on Awakening [Time frame: 2 years]
Secondary outcome measures (2)
- RASS Scale score [Time frame: 2 years]
- NRS scale score [Time frame: 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
Identifiers
NCT: NCT06844838 · FasTrack