The Electroencephalogram and Clinical Effect of Ketamine

The Effect of Ketamine Between Generations in Operation Theater- Focus on Electroencephalogram Changes

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.

Study Overview

• Status: Terminated
• Conditions: Electroencephalogram; Consciousness, Loss of
• Intervention / Treatment: Drug: Ketamine

Detailed Description

Method: In the first year, we will record 60 patients who received general anesthesia, their EEG data recorded from bi-spectral index (BIS) monitor. Under the same anesthesia depth, the experimental group use ketamine 0.5mg/kg; while the control group using alfentanil 0.01mg/kg injection. Both perioperative data were recorded included heart rate, blood pressure and surgical time. We decompose the raw EEG data from BIS monitor with EMD, and we observe difference between IMFs, and quantifying energy change. Second year: We will extend the EEG monitor to temporal lobe, parietal lobe and occipital lobe. Besides the whole brain mapping method for detecting energy change after ketamine injection; we also tried to find the interactions between oscillations. Finally, we want to apply the analysis method to pediatric patients, try to find the difference of ketamine reaction between generations. Anticipated Results: We anticipate that we can quantify the energy of EEG by Emperical mode decomposition(EMD), and ketamine injection can cause different energy change with other sedatives. We will find the energy traveling in EEG with EMD decomposition. We will find that HHT is more suitable for EEG analysis in clinical practicing. With the whole brain mapping method, we can understand the electrical activity during general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

patient refuse not suitable for propofol or ketamine injection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-20 y/o; 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; With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.; Other Names: control
Experimental: 20-40y/o group; 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; With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.; Other Names: control
Experimental: >70 y/o; 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; With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ketamine increase the dissociation energy in EEG	ANOVA measurement	one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 201605031RINC

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