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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 18 years

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

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)

Time frame
2 years

Other outcomes

Sponsors and contacts

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