NCT02878707

Brief Summary

Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

September 22, 2020

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

August 15, 2016

Last Update Submit

September 20, 2020

Conditions

Brain TumorCerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative neurological complications

    during postoperative period of hospital admission, approximately 10 days by estimation

Secondary Outcomes (3)

  • Number of participants with postoperative delirium

    during postoperative period of hospital admission, approximately 10 days by estimation

  • Serum biomarkers changes

    Between preoperative baseline and postoperative day one.

  • Intraoperative haemodynamic profile

    during intraoperative perioid, approximately 4-6 hours by estimation

Study Arms (2)

DEX

EXPERIMENTAL

Intraoperative intravenous infusion of dexmedetomidine

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

Intraoperative intravenous infusion of 0.9% saline

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Intraoperative dexmedetomidine infusion

ControlDEX

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
  • 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

Location

Related Publications (1)

  • Chen PH, Tsuang FY, Lee CT, Yeh YC, Cheng HL, Lee TS, Chang YW, Cheng YJ, Wu CY. Neuroprotective effects of intraoperative dexmedetomidine versus saline infusion combined with goal-directed haemodynamic therapy for patients undergoing cranial surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Dec 1;38(12):1262-1271. doi: 10.1097/EJA.0000000000001532.

    PMID: 34101714DERIVED

MeSH Terms

Conditions

Brain NeoplasmsCerebrovascular Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chun-Yu Wu, MD

    Anesthesiology Department, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 25, 2016

Study Start

April 24, 2017

Primary Completion

April 14, 2020

Study Completion

April 14, 2020

Last Updated

September 22, 2020

Record last verified: 2016-08

Locations

TW(1)