Ketamine in Deep Brain Stimulation (DBS) Surgery

NCT04716296 | Completed

• 1 other identifier: 0328-20-RMC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Deep brain stimulation (DBS) is a well-established and effective treatment for motor symptoms resulting from idiopathic Parkinson's disease (PD). During the DBS surgery , a brain electrode is implanted in the basal ganglia, which is involved in the pathophysiology of the disease. The surgery consists of three steps: 1. Opening the skin, drilling the skull bone and inserting a temporary electrode. 2. Recording electrical activity of the brain, electrical stimulation of the brain which guide the implantation of the electrode.3 Transferring wires and implanting a subcutaneous pacemaker battery in the chest area. Today, standard treatment protocols consist undergoing the second stage (or first and second stage, depending on the treatment center protocol) of the surgery awake (under local anesthesia only). As systemic anesthetics affect cerebral electrical activity and prevent patient cooperation, they inhibit precise identification of the cerebral target under 'physiological navigation' guided by electrical recording and brain stimulation. As a result, the accuracy of electrode implantation decreases. However, undergoing surgery in an awake format often causes severe patient discomfort and anxiety necessitating shortening the length of surgery or aborting the surgery. As such there is a need for establishing an alternative anesthesia protocol for DBS surgeries. Ketamine is considered a unique anesthetic due to its hypnotic properties, analgesia, and possible amnesia. Standard doses of ketamine are currently used worldwide to treat patients with various injuries and brain diseases. Research from monkeys has shown that ketamine (in low dose) does not affect electrical brain activity used for physiological navigation. The investigators therefore propose a prospective , randomized , blinded study to evaluate the utility of low dose of ketamine in the second stage of DBS surgeries for increasing patient satisfaction and cooperation without detracting from the accuracy of physiological navigation to the cerebral target. This study will compare two treatment arms : Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

Conditions

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Electrophysiological recordings MER, Local field potentials and multiunit activity

  Efficacy of Ketamine for use of the second stage of DBS surgery

  During surgery

Secondary Outcomes (3)

• Side effects from ketamine use

  During surgery

• The participants neurological status

  During surgery

• Patients satisfaction levels measured using owa Satisfaction with Anesthesia Scale

  Up to two weeks postoperatively

Study Arms (2)

Ketamine arm

EXPERIMENTAL

Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery.

Drug: Ketamine

Control arm

ACTIVE COMPARATOR

Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

Drug: Saline

Interventions

Ketamine DRUG

Ketamine will be given for the second stage of the DBS surgery.

Ketamine arm

Saline DRUG

Saline will be given for the second stage of the DBS surgery.

Control arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above
• Patients with history of Parkinson's disease
• Patients undergoing deep brain stimulation surgery on subthalamic nucleus from the neurology and the neurosurgery at Beilinson hospital
• Patients with the ability to comply with the study requirements and undergoing Patients whom fulfill all above requirements will be approached for enrollment.

You may not qualify if:

• Patients who can't cooperate and fulfill study requirements.
• Patients who are at increased risk for performing study related tasks

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Idit O Tamir, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: blinded: The participant , the neurologist, the neurophysiologist and neuropsychologist treating the participant will be blinded to the randomization arm. The neurosurgeon and anesthesiologist assigned to the patient will be unblinded to the randomization arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of DBS surgery unit

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: January 20, 2021
• Study Start: January 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: December 31, 2023
• Last Updated: April 11, 2024

Record last verified: 2023-03

Locations

IL (1)