NCT03927963

Brief Summary

The brain protection effect of dexmedetomidine has been approved in several studies. Basically, the anti-inflammatory effects and reducing catecholamines are thought to be a main role of the protection effect. In many studies reported the advantage of dexmedetomidine as a substitution of other sedative drugs for anesthesia. The anesthesia of intra-cranial aneurysmal clipping operation commonly use intravenous anesthetic agents combined with inhalation anesthesia for neuroprotection, and mostly propofol is used. The aim of this study is to examine the effects of dexmedetomidine on serum inflammatory markers and research the hemodynamic stability of dexmedetomidine compared to propofol in aneurysmal clipping operation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

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

March 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

March 12, 2019

Last Update Submit

April 24, 2019

Conditions

Dexmedetomidine

Outcome Measures

Primary Outcomes (12)

  • The concentration of inflammatory markers

    CRP (mg/ml)

    Baseline: Before injection study drugs

  • The concentration of inflammatory markers

    CRP (mg/ml)

    1 minute after operation

  • The concentration of inflammatory markers

    CRP (mg/ml)

    Day 1 after operation

  • The concentration of inflammatory markers

    CRP (mg/ml)

    Day 2 after operation

  • The concentration of norepinephrine

    NE (nmol/l)

    Baseline: Before injection study drugs

  • The concentration of norepinephrine

    NE (nmol/l)

    1 minute after operation

  • The concentration of norepinephrine

    NE (nmol/l)

    Day 1 after operation

  • The concentration of norepinephrine

    NE (nmol/l)

    Day 2 after operation

  • The concentration of inflammatory markers

    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

    Baseline: Before injection study drugs

  • The concentration of inflammatory markers

    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

    1 minute after operation

  • The concentration of inflammatory markers

    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

    Day 1 after operation

  • The concentration of inflammatory markers

    IL-6, IL-8, IL-10 ,TNF-a (pg/ml)

    Day 2 after operation

Secondary Outcomes (1)

  • The frequency of hypotension or hypertension

    during operation

Study Arms (2)

propofol

PLACEBO COMPARATOR
Drug: Propofol

dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

dexmedetomidine
PropofolDRUG

Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

propofol

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I,II patient needs operation of intracranial aneurysmal clipping without SAH

You may not qualify if:

  • Any history of neurologic disease, dementia
  • Allergic history of propofol or dexmedetomidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexmedetomidinePropofol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 12, 2019

First Posted

April 25, 2019

Study Start

May 1, 2019

Primary Completion

September 30, 2020

Study Completion

February 28, 2021

Last Updated

April 25, 2019

Record last verified: 2019-04