NCT06844838

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 7, 2025

Last Update Submit

February 10, 2026

Conditions

Supratentorial Brain Tumor Surgery

Keywords

General AnaesthesiaBISBispectral IndexNOLNocipection LevelNeuroanesthesiaTarget Colled Infusion TCICraniectomyAwakeningERASFast TrackPropofolRemifentanilPainNociceptionRASS

Outcome Measures

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.

    2 years

Secondary Outcomes (2)

  • RASS Scale score

    2 years

  • NRS scale score

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age greater than or equal to 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Carla Carozzi, M.D.

CONTACT

+39 02 2394carla.carozzi@istituto-besta.it

Marco Gemma, M.D.

CONTACT

+ 39 02 2394marco.gemma@istituto-besta.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 25, 2025

Study Start

January 19, 2024

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)