Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention

NCT06521645 | Completed

• 1 other identifier: XJH-A-20240626
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

It is advocated that neuroprotection should be increased before endovascular treatment and that the penumbra should be protected from reperfusion damage after recanalization. Monitoring lactate and pH levels in acute ischemic stroke patients who have had endovascular recanalization can be utilized to predict mortality and morbidity, especially in the first five hours after the procedure. This study aims to observe the effect of acupoint stimulation on lactate level during endovascular recanalization.

Conditions

Endovascular Procedures

Keywords

acupoint stimulation; cerebral endovascular intervention; lactate

Outcome Measures

Primary Outcomes (1)

• arterial level of lactate at 30 minutes after recanalization

  30 minutes after recanalization

Secondary Outcomes (18)

• arterial level of lactate immediately after recanalization

  about 1 minute after recanalization

• pH value at 30 minutes after recanalization

  30 minutes after recanalization

• Concentration of HCO3- at 30 minutes after recanalization

  30 minutes after recanalization

• Concentration of base excess at 30 minutes after recanalization

  30 minutes after recanalization

• partial pressure of oxygen at 30 minutes after recanalization

  30 minutes after recanalization

Study Arms (2)

Acupoint stimulation

EXPERIMENTAL

needles are inserted into the skin of Baihui acupoint, and electrical acupoint stimulation is given

Other: electroacupuncture

Control

SHAM COMPARATOR

needles are shallowly inserted into the skin of Bihui acupoint, but no electrical acupoint stimulation is given

Other: sham needle

Interventions

electroacupuncture OTHER

electrical stimulation is given through needles inserted into the skin

Acupoint stimulation

sham needle OTHER

needles are inserted shallowly into the skin

Control

Eligibility Criteria

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

You may qualify if:

• age ≥18 years
• scheduled for cerebral endovascular intervention

You may not qualify if:

• American Society of Anesthesiologists status over level three
• history of cerebral vascular intervention
• history of severe neurological disease (stroke, neurological degenerative disease, psychiatric disease)
• severe hepatic or renal dysfunction
• severe glucose disorder or thyroid dysfunction
• contraindications to transcutaneous electrical stimulation (infection or injury of the skin area, implanted electrical devices)

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, China

Location

Related Publications (2)

• Garzelli L, Nuzzo A, Hamon A, Ben Abdallah I, Gregory J, Raynaud L, Paulatto L, Dioguardi Burgio M, Castier Y, Panis Y, Vilgrain V, Corcos O, Ronot M. Reperfusion injury on computed tomography following endovascular revascularization of acute mesenteric ischemia: prevalence, risk factors, and patient outcome. Insights Imaging. 2022 Dec 13;13(1):194. doi: 10.1186/s13244-022-01339-9.

  PMID: 36512135 BACKGROUND

• Onalan A, Gurkas E, Akpinar CK, Dogan H, Acar T, Acar B, Aykac O, Uysal Kocabas Z, Balgetir F, Ozdemir AO. Arterial blood gas analysis predicts futile recanalization in mechanical thrombectomy-treated acute ischemic stroke patients: a multicenter study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1594-1604. doi: 10.26355/eurrev_202402_35488.

  PMID: 38436197 RESULT

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 26, 2024
• Study Start: October 30, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)