EC50 of Dexmedetomidine in Deep Brain Stimulation Implantation of Patients With Parkinson's Disease

NCT05376761 | Unknown Phase 4 DMC

• 1 other identifier: xsn20220314
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine (DEX) sedation is widely used in deep brain stimulation implantation (DBSI) of patients With Parkinson's disease. However, intraoperative application of DEX may affect the discharge activity of deep brain nuclei and reduce the discharge frequency of Subthalamic nucleus (STN) neurons. At present, there is still a lack of prospective intervention research to explore the optimal dose that does not affect MER mapping in patients with Parkinson's disease. The present study uses the Dixon and Massey up-and-down method to analyze the EC50 of DEX in patients with PD undergoing STN-DBS sedation, to clarify the balance meets the sufficient comfort of patients without affecting the accurate target of MER and the optimal dosage of DEX for boundary recognition.

Conditions

PD - Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• EC50 and the corresponding 95%CI of DEX applied to PD patients undergoing STN-DBS are determined by the up and down method according to the normalized root mean square(NRMS) value of the MER sampled signal.

  We use the root mean square (RMS) value of the MER sampled signal recorded by the electrode, measured in volts, 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. If the NRMS is higher than 2.0, a positive response is defined and the concentration of DEX will be added by 0.05µg/kg/h in the next patient. A negative response is defined as NRMS lower than 2.0, and in such cases the concentration of DEX is reduced by 0.3 µg/kg/h.

  during MER recording

Secondary Outcomes (1)

• STN pass length (mm)

  during MER recording

Study Arms (1)

DEX for STN-DBS

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

The loading dose of DEX (0.5 µg/kg) is transfused intravenously within 15min.The maintaining concentration of DEX, which is started at 0.3 µg/kg/h in the first patient, is determined by the NRMS in the MER signal of the previous patient according to the up and down sequence. If the NRMS is higher than 2.0, a positive response is defined and the concentration of DEX will be added by 0.05µg/kg/h in the next patient. A negative response is defined as NRMS lower than 2.0, and in such cases the concentration of DEX is reduced by 0.3 µg/kg/h.

DEX for STN-DBS

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;
• Bilateral STN-DBS of patients with Parkinson's disease;
• 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 such as heart, liver and kidney;
• previous allergy to dexmedetomidine;
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dexmedetomidine

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)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 17, 2022
• Study Start: May 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

CN (1)