Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention (ASLA)

The Effect of Acupoint Stimulation on Level of Lactate in Patients Undergoing Cerebral Endovascular Intervention

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.

Study Overview

• Status: Completed
• Conditions: Endovascular Procedures
• Intervention / Treatment: Other: electroacupuncture; Other: sham needle

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • the First Affiliated Hospital of the Air Force Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥18 years
• scheduled for cerebral endovascular intervention

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupoint stimulation; needles are inserted into the skin of Baihui acupoint, and electrical acupoint stimulation is given	Other: electroacupuncture; electrical stimulation is given through needles inserted into the skin
Sham Comparator: Control; needles are shallowly inserted into the skin of Bihui acupoint, but no electrical acupoint stimulation is given	Other: sham needle; needles are inserted shallowly into the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial level of lactate at 30 minutes after recanalization	30 minutes after recanalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
partial pressure of carbon dioxide at 30 minutes after recanalization		30 minutes after recanalization
pH value immediately after recanalization		about 1 minute after recanalization
Concentration of HCO3- immediately after recanalization		about 1 minute after recanalization
Concentration of base excess immediately after recanalization		about 1 minute after recanalization
partial pressure of oxygen immediately after recanalization		about 1 minute after recanalization
partial pressure of carbon dioxide immediately after recanalization		about 1 minute after recanalization
Concentration of serum interleukin-6 at 30 minutes after recanalization		30 minutes after recanalization
Concentration of serum tumor necrosis factor α at 30 minutes after recanalization		30 minutes after recanalization
Concentration of serum brain-derived neurotrophic factor at 30 minutes after recanalization		30 minutes after recanalization
score of modified Rankin's scale at 24 hours after recanalization	the minimum and maximum values of modified Rankin's scale is 0 and 5, and higher scores mean a worse outcome.	24 hours after recanalization
incidence of stroke during hospitalization		From end of surgery to discharge from hospital, at an average of 5 days
Incidence of death during hospitalization		From end of surgery to discharge from hospital, at an average of 5 days
length of hospitalization		From end of surgery to discharge from hospital, at an average of 5 days

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: lactate; acupoint stimulation; cerebral endovascular intervention
• Other Study ID Numbers: XJH-A-20240626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No