The Neuroprotection Effect of Dexmedetomidine

The Anti-inflammatory Effect and Hemodynamic Stability of Dexmedetomidine in Aneurysmal Clipping Operation; Compare With Propofol

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.

Study Overview

• Status: Unknown
• Conditions: Dexmedetomidine
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: propofol	Drug: Propofol; Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period
Active Comparator: dexmedetomidine	Drug: Dexmedetomidine; Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The frequency of hypotension or hypertension	during operation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: AJIRB-MED-OBS-18-478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No