NCT06244017

Brief Summary

In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 29, 2024

Last Update Submit

February 5, 2024

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (1)

  • Intraoperative anesthetic dose

    We aim to compare the intraoperative propofol consumptions between the two study groups

    4-6 hours

Secondary Outcomes (1)

  • Postoperative neurological complication incidence

    During the hospital stays; approximately 7-10 days

Study Arms (2)

EEG Spectrogram-guided

EXPERIMENTAL

The general anesthesia administration is guided by using the EEG spectrogram in this group. Other perioperative care protocols are the same between the two study group.

Device: EEG spectrogram

Bispectral index-guided

ACTIVE COMPARATOR

The general anesthesia administration is guided by using the processed EEG index, namely the bispectral index (BIS) in this group. Other perioperative care protocols are the same between the two study group.

Device: Bispectral index

Interventions

EEG spectrogramDEVICE

In the experimental group, the general anesthesia is guided by using the EEG spectrogram.

EEG Spectrogram-guided
Bispectral indexDEVICE

In the control group, the general anesthesia is guided by using the bispectral index

Bispectral index-guided

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective craniotomy

You may not qualify if:

  • revision surgery
  • heart failure
  • liver cirrhosis \> Child B class
  • chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 300, Taiwan

RECRUITING

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital Hsinchu Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Wu

CONTACT

886976653376b001089018@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 7, 2024

Record last verified: 2024-01

Locations

TW(1)