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

NCT ID: NCT05376761

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-12-31

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.

Detailed Description

Deep brain stimulation (DBS) is an effective treatment to improve the motor symptoms of Parkinson's disease (PD). Subthalamic nucleus (STN) is one of the most commonly used targets in the treatment of PD-DBS. The accuracy of the final implantation position of deep brain electrodes is the key to the success of surgery.

Sedation-Awake-Sedation anesthesia is widely used in DBS. Dexmedetomidine (DEX) mainly acts on the central locus coeruleus nucleus and spinal cord α receptor, which has sedative and analgesic effect and little respiratory inhibition. DEX can produce natural non eye movement sleep that is conducive to the recovery of the body. Within a certain dose range, patients are easy to wake up and have the characteristics of conscious sedation. Patients can make corresponding actions according to the instructions of neurosurgeons and cooperate with doctors to complete the operation. Its sedative safety has been confirmed.

However, intraoperative application of DEX may delay the recovery of cognitive function, affect the discharge activity of deep brain nuclei and reduce the discharge frequency of STN neurons, even after stopping the use of sedatives. The result may be related to the residual effect of sedatives. DEX can reduce the activity of STN neurons in a dose-dependent manner. A smaller dose of DEX may not meet the effects of surgical sedation and analgesia, and the effect of high concentration is better than that of low concentration. Some existing studies have recommended a reasonable dose range of DEX for DBS, but these studies have a small number of research populations, and of great heterogeneity in target selection, anesthetic dose and strategy. At present, there is still a lack of prospective intervention research to explore the optimal dose that the application of DEX sedation does not affect MER mapping in patients with Parkinson's disease. The present study uses the up and down method to analyze the EC50 and EC95 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DEX for STN-DBS

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 50-80 years old, ASA grade II-III;

2. Bilateral STN-DBS of patients with Parkinson's disease;

3. Signed informed consent.

Exclusion Criteria

1. Obstructive sleep apnea;

2. BMI > 30kg/m2;

3. Estimated difficult airway;

4. Severe preoperative anxiety;

5. Serious dysfunction of important organs such as heart, liver and kidney;

6. previous allergy to dexmedetomidine;

7. Pregnant or lactating women.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Director of Anesthesiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruquan Han, MD, PhD

Role: CONTACT

ruquan.han@gmail.com

8610-59976660

Facility Contacts

Si-Ning Xie

Role: primary

xiesining101@sina.com

Other Identifiers

xsn20220314

Identifier Type: -

Identifier Source: org_study_id