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Ketamine Clinical Trials


Intraoperative Use of Ketamine for Awake Deep Brain Stimulation (DBS) Surgery Compared to Standard Procedure


To see complete record on clinicaltrials.gov, please visit this link

Id: NCT04716296

Organisation Name: Rabin Medical Center

Overal Status: Recruiting

Start Date: January 1, 2021

Last Update: March 10, 2021

Lead Sponsor: Rabin Medical Center

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


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