Supratentorial Brain Tumor Surgery
Conditions
Keywords
General Anaesthesia, BIS, Bispectral Index, NOL, Nocipection Level, Neuroanesthesia, Target Colled Infusion TCI, Craniectomy, Awakening, ERAS, Fast Track, Propofol, Remifentanil, Pain, Nociception, RASS
Brief summary
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.
Interventions
None listed
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Anaesthesia effect on Awakening | 2 years | Correlation between intraoperative dosage of Propofol and Remifentanil with respect to dichotomous outcome related to quality of awakening post GA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RASS Scale score | 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. |
| NRS scale score | 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) |
Countries
Italy
Contacts
CONTACTCarla Carozzi, M.D.
CONTACTMarco Gemma, M.D.
Outcome results
None listed