UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia

Parkinson Disease Clinical Trial

Official title:

UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361188
• Other study ID #: FS20191119007
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.

Description:

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years old
• Diagnosis of primary Parkinson's disease
• Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.

Exclusion Criteria:

• Refusal to Participate in the research
• Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
• Previous functional neurosurgery: DBS, thalamic incision, etc.

Related Conditions & MeSH terms

• Anesthesia
• Parkinson Disease

Intervention

Procedure:
• MAC anesthesia
Patients receives DBS under monitored anesthesia care.
• AAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Pa — View Citation

Chen T, Mirzadeh Z, Chapple KM, Lambert M, Evidente VGH, Moguel-Cobos G, Oravivattanakul S, Mahant P, Ponce FA. Intraoperative test stimulation versus stereotactic accuracy as a surgical end point: a comparison of essential tremor outcomes after ventral i — View Citation

Chen T, Mirzadeh Z, Chapple KM, Lambert M, Shill HA, Moguel-Cobos G, Tröster AI, Dhall R, Ponce FA. Clinical outcomes following awake and asleep deep brain stimulation for Parkinson disease. J Neurosurg. 2018 Mar 16;130(1):109-120. doi: 10.3171/2017.8.JNS — View Citation

Erickson KM, Cole DJ. Anesthetic considerations for awake craniotomy for epilepsy and functional neurosurgery. Anesthesiol Clin. 2012 Jun;30(2):241-68. doi: 10.1016/j.anclin.2012.05.002. Epub 2012 Jul 3. Review. — View Citation

Grant R, Gruenbaum SE, Gerrard J. Anaesthesia for deep brain stimulation: a review. Curr Opin Anaesthesiol. 2015 Oct;28(5):505-10. doi: 10.1097/ACO.0000000000000230. Review. — View Citation

Ho AL, Ali R, Connolly ID, Henderson JM, Dhall R, Stein SC, Halpern CH. Awake versus asleep deep brain stimulation for Parkinson's disease: a critical comparison and meta-analysis. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):687-691. doi: 10.1136/jnnp-2 — View Citation

Ho AL, Pendharkar AV, Brewster R, Martinez DL, Jaffe RA, Xu LW, Miller KJ, Halpern CH. Frameless Robot-Assisted Deep Brain Stimulation Surgery: An Initial Experience. Oper Neurosurg (Hagerstown). 2019 Oct 1;17(4):424-431. doi: 10.1093/ons/opy395. — View Citation

Kochanski RB, Sani S. Awake versus Asleep Deep Brain Stimulation Surgery: Technical Considerations and Critical Review of the Literature. Brain Sci. 2018 Jan 19;8(1). pii: E17. doi: 10.3390/brainsci8010017. Review. — View Citation

Krauss P, Marahori NA, Oertel MF, Barth F, Stieglitz LH. Better Hemodynamics and Less Antihypertensive Medication: Comparison of Scalp Block and Local Infiltration Anesthesia for Skull-Pin Placement in Awake Deep Brain Stimulation Surgery. World Neurosurg — View Citation

Kulikov A, Lubnin A. Anesthesia for awake craniotomy. Curr Opin Anaesthesiol. 2018 Oct;31(5):506-510. doi: 10.1097/ACO.0000000000000625. Review. — View Citation

Sheshadri V, Rowland NC, Mehta J, Englesakis M, Manninen P, Venkatraghavan L. Comparison of General and Local Anesthesia for Deep Brain Stimulator Insertion: A Systematic Review. Can J Neurol Sci. 2017 Nov;44(6):697-704. doi: 10.1017/cjn.2017.224. Epub 20 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores' change of Unified Parkinson's Rating Scale (part III/motor part)	Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.	Before and six-month after DBS.
Secondary	Change of Levodopa Equivalent Dose	Compares the change of Levodopa equivalent dose between the two groups.	Before and six-month after DBS.
Secondary	Rates of Adverse Events	Compares the rates of adverse events between the two groups.	Intra-operative.
Secondary	Dosage of Anesthetic Drugs	Compares the dosage of anesthetic between the two groups.	Within surgery.
Secondary	Wake-up Time	Compares the wake-up time between the two groups.	Within surgery.
Secondary	Surgical Time	Compares the surgical time between the two groups.	Within surgery.
Secondary	Hoehn&Yahr	Compares the Hoehn&Yahr classification between the two groups' patients.	Before surgery.
Secondary	Patients' Satisfaction(Visual Analogue Scale)	Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction.	24 hours after surgery.
Secondary	Scores' change of 39-item Parkinson's Disease Questionnaire	Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.	Before and six-month after DBS.
Secondary	Scores' change of Mini-mental State Examination	Compares the scores' change of Mini-mental State Examination between the two groups.	Before and six-month after DBS.
Secondary	Scores' change of Montreal Cognitive Assessment	Compares the scores' change of Montreal Cognitive Assessment between the two groups.	Before and six-month after DBS.
Secondary	Scores' change of Hamilton Anxiety Scale	Compares the scores' change of Hamilton Anxiety Scale between the two groups.	Before and six-month after DBS.
Secondary	Scores' change of Hamilton Depression Scale	Compares the scores' change of Hamilton Depression Scale between the two groups.	Before and six-month after DBS.