NCT05656547

Brief Summary

Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

December 11, 2022

Last Update Submit

December 19, 2022

Conditions

Brain Surgery

Keywords

electroencephalogramdexmedetomidinetotal intravenous anesthesiacraniotomy

Outcome Measures

Primary Outcomes (1)

  • Propofol dose requirement

    Intraoperative propofol consumption

    4-6 hours

Secondary Outcomes (2)

  • Postoperative delirium

    During hospital stay, estimated 7-10 days

  • Postoperative Barthel index change

    During hospital stay, estimated 7-10 days

Study Arms (2)

Encephalographic spectrogram group

The dexmedetomidine and propofol infusions were titrated to maintain robust alpha power in the encephalographic spectrogram

Encephalographic index group

The dexmedetomidine and propofol infusions were titrated to maintain the bispectral index score between 40 and 60.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression.

You may qualify if:

  • Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression
  • age between 20 to 80 yr

You may not qualify if:

  • Fever, elevated white blood cell or C-reactive protein
  • Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
  • Impaired renal function, cGFR\< 60 ml/min/1.73 m2
  • Cardiac dysfunction, such as heart failure \> NYHA class II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Wu

CONTACT

886-2-23562158b001089018@tmu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2022

First Posted

December 19, 2022

Study Start

December 12, 2022

Primary Completion

January 25, 2023

Study Completion

February 25, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

TW(1)