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NCT Number: NCT06844838

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location status: Recruiting

Location contact

Carla Carozzi, MD

CONTACT

[email protected]

+ 39 02 2394 ext. 2420

Carla Carozzi, MD

PRINCIPAL_INVESTIGATOR

Marco Gemma, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. General Anaesthesia effect on Awakening

    Time frame: 2 years

    Correlation between intraoperative dosage of Propofol and Remifentanil with respect to dichotomous outcome related to quality of awakening post GA.

Secondary outcomes

  1. RASS Scale score

    Time frame: 2 years

    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. NRS scale score

    Time frame: 2 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Carozzi, M.D.

CONTACT

[email protected]

+39 02 2394 ext. 2420

Marco Gemma, M.D.

CONTACT

[email protected]

+ 39 02 2394 ext. 2420

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Acronym: FasTrack

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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