Clinical trial NCT06521645: Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention
Official title: The Effect of Acupoint Stimulation on Level of Lactate in Patients Undergoing Cerebral Endovascular Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endovascular Procedures
Keywords: acupoint stimulation
cerebral endovascular intervention
lactate
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: arterial level of lactate at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
Secondary outcomes:
measure: arterial level of lactate immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: pH value at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: Concentration of HCO3- at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: Concentration of base excess at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: partial pressure of oxygen at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: partial pressure of carbon dioxide at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: pH value immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: Concentration of HCO3- immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: Concentration of base excess immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: partial pressure of oxygen immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: partial pressure of carbon dioxide immediately after recanalization
timeFrame: about 1 minute after recanalization
measure: Concentration of serum interleukin-6 at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: Concentration of serum tumor necrosis factor α at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: Concentration of serum brain-derived neurotrophic factor at 30 minutes after recanalization
timeFrame: 30 minutes after recanalization
measure: score of modified Rankin's scale at 24 hours after recanalization
timeFrame: 24 hours after recanalization
measure: incidence of stroke during hospitalization
timeFrame: From end of surgery to discharge from hospital, at an average of 5 days
measure: Incidence of death during hospitalization
timeFrame: From end of surgery to discharge from hospital, at an average of 5 days
measure: length of hospitalization
timeFrame: From end of surgery to discharge from hospital, at an average of 5 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital of the Air Force Military Medical University
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.