The Electroencephalogram and Clinical Effect of Ketamine

NCT03679390 | Terminated

• 1 other identifier: 201605031RINC
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang Transformation (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF). HHT can obtain instantaneous frequency data and work well for nonstationary and nonlinear data. We applied this method in perioperative EEG signal analysis in order to find the energy shift and quantify the energy change during general anesthesia. Ketamine was a depolarized sedative which was wildly used in anesthesia. We are trying to find the energy change after ketamine injection, and the interaction between different oscillations in EEG. The whole brain mapping for ketamine and other sedatives interaction is the next step.

Conditions

Electroencephalogram; Consciousness, Loss of

Outcome Measures

Primary Outcomes (1)

• Ketamine increase the dissociation energy in EEG

  ANOVA measurement

  one year

Study Arms (3)

10-20 y/o

EXPERIMENTAL

We will include the teenagers who need intravenous general anesthesia(IVGA), and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

Drug: Ketamine

20-40y/o group

EXPERIMENTAL

We will include patients who need IVGA, and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

Drug: Ketamine

>70 y/o

EXPERIMENTAL

We will include patients who need IVGA, and inject propofol with/without ketamine 0.5mg/kg with full monitor. We will record the EEG during the who operation.

Drug: Ketamine

Interventions

Ketamine DRUG

With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.

Also known as: control

10-20 y/o; 20-40y/o group; >70 y/o

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology I-II Not allergic to BIS probe Do not have wound or scar over forehead area

You may not qualify if:

• patient refuse not suitable for propofol or ketamine injection

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Unconsciousness

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use same medication for different generations, focus on the reactions.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: March 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 6, 2021

Record last verified: 2020-06

Locations

TW (1)