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Ketodex vs Dexmedetomidine in Awake Mapping for Deep Brain Stimulation

NCT07513935Phase 4

Key facts

Status: Active, not recruiting
Start: Mar 2026
Primary completion: Sep 2026
Countries: 1
Sponsor: Ain Shams University
Modality: Small Molecules

Drugs: ketamine
Conditions: movement disorders

Overview

Phase 4, randomised, double-blind trial of ketamine in movement disorders (2 arms), sponsored by Ain Shams University. Primary endpoint: Normalized Root Mean Square Assessment. Started Mar 2026; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Group I (KD1)
Ketamine + Dexmedetomidine
Group II (D2)
Dexmedetomidine alone

Who it enrols

Adults aged 18-75 with movement disorders undergoing awake DBS surgery, ASA physical status I-III, able to cooperate. Excludes patients with severe cardiac, respiratory, or hepatic disease, psychiatric disorders, allergy to local anesthetics, heart block, heart failure, liver cirrhosis, thrombocytopenia, coagulopathies, or severe bradycardia.

Endpoints

Primary

Normalized Root Mean Square Assessmentperioperative period

Secondary

Total Rescue Analgesiaperioperative period
Time to Awakeness/Recoveryperioperative period
Neurocognitive Assessment24 hours postoperatively
Incidence of hypotension and bradycardiaperioperative period

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