Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease

NCT05550714 | Recruiting DMC

• 1 other identifier: xsn20220618
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Subthalamic nucleus (STN)-deep brain stimulation (DBS) under general anesthesia has been applied to PD patients who cannot tolerate awake surgery, but general anesthesia will affect the electrical signal in microelectrode recording (MER) to some degree. This study is a prospective randomized controlled, noninferiority study, open label, endpoint outcome evaluator blinded, two-arm study. Parkinson's disease patients undergoing STN-DBS are randomly divided into a conscious sedation group (dexmedetomidine) and a general anesthesia group (desflurane). Normalized root mean square (NRMS) is used to compare the difference of neuronal activity between the two groups. The primary outcome is the percentage of high NRMS recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0). The secondary outcomes are the NRMS, length of the STN, number of MER tracks, and differences in clinical outcomes 6 months after the operation.

Conditions

PD - Parkinson's Disease; Dexmedetomidine; Desflurane; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).

  We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.

  1 day (during MER recording)

Secondary Outcomes (15)

• NRMS and their stratified proportions in the CS and GA groups

  1 day (during MER recording)

• Firing rates

  1 day (during MER recording)

• Lengths of STN(mm)

  1 day (during MER recording)

• Total electrode path times

  1 day (during MER recording)

• Beta band (13-30 Hz) oscillations calculated by spectrum analysis

  1 day (during MER recording)

Study Arms (2)

General anesthesia

EXPERIMENTAL

Drug: general anesthesia

Conscious sedation

ACTIVE COMPARATOR

Drug: Conscious sedation

Interventions

general anesthesia DRUG

The patients did not use any preoperative sedative drugs and were given sufentanil citrate 0.1-0.2 µg/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction. After the patients were unconscious, oral endotracheal intubation was performed. Anesthesiologists should continuously monitor PetCO2 and maintain PetCO2 at 30-35 mmHg. During the operation, patients are treated with remifentanil, cisatracurium, and desflurane inhalation at 0.5-1.0 minimum alveolar concentration (MAC). In the MER process, the desflurane concentration is adjusted to maintain 0.5-0.6 MAC. If the desflurane concentration needs to be adjusted to less than 0.5 MAC during MER for various reasons, remedial measures will be implemented.

General anesthesia

Conscious sedation DRUG

A loading dose of DEX 0.5 µg/kg was infused intravenously at a constant speed within 15 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.2-0.5 µg/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. Maintain the BIS value at 60-80.

Also known as: asleep-awake-asleep anesthesia

Conscious sedation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.

You may not qualify if:

• Obstructive sleep apnea;
• BMI \> 30kg/m2;
• Estimated difficult airway;
• Severe preoperative anxiety;
• Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)
• A history of allergy to the anaesthetics.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

Related Publications (1)

• Xie S, Shi L, Xiong W, Chen L, Li X, Tong Y, Yang W, Wang A, Zhang J, Han R. Choice of anaesthesia in microelectrode recording-guided deep-brain stimulation for Parkinson's disease (CHAMPION): study protocol for a single-centre, open-label, non-inferiority randomised controlled trial. BMJ Open. 2023 May 30;13(5):e071726. doi: 10.1136/bmjopen-2023-071726.

  PMID: 37253497 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Anesthesia, General; Conscious Sedation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Ruquan Han, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruquan Han, MD, PhD

CONTACT

8610-59976660; ruquan.han@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: October 15, 2022
• Primary Completion: March 26, 2024
• Study Completion: September 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)