The aim of this study was toinvestigate the effect of BPB on outcome of upper extremity arteries in patients undergoing interventional embolization of intracranial aneurysms via TRA. A multicenter prospective clinical trial was designed. The study subjects were patients undergoing cerebral aneurysm embolization with TRA. BPB was given in the BPB group patients and no BPB in the control group.The incidence of radial artery spasm (RAS) diagnosed by intraoperative angiography and the occurrence of the unfavorable RA for repeated trans-radial interventions (TRI) diagnosed by vascular ultrasound 1 month after surgery， perioperative changes of blood flow parameters in upper limb vessels,postoperative inflammatory factors and complications were observed in the two groups.
The aim of this study was to investigate the effect of BPB on outcome of upper extremity arteries in patients undergoing interventional embolization of intracranial aneurysms via TRA. A multicenter prospective clinical trial was designed, and the study subjects were patients undergoing cerebral aneurysm embolization with TRA. Participants were randomly assigned to receive Ultrasound-guided BPB with 0.15% ropivacaine 20ml (BPB group) or normal saline 20ml (Control group) in 1:1ratio.The primary outcomes measured were the incidence of RAS diagnosed by intraoperative angiography and the occurrence of the unfavorable RA for repeated trans-radial interventions (TRI) diagnosed by vascular ultrasound 1 month after surgery.Secondary outcomes included the severity of RAS, Components of unfavorable RA for repeated TRI, intraoperative nitroglycerin use, Intraoperative hypotension, surgeon satisfaction scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
176
According to the results of the preliminary experiment, the BPB group was given ultrasound-guided BPB with 0.15% ropivacaine 20ml.The ropivacaine concentration was the 90% minimum effective concentration(MEC90) for preventing vasospasm during operation.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGAssess the RAS by angiography at the begining of the operation
The RAS was assessed through radial artery angiography following the insertion of the arterial catheter.
Time frame: During the operation
Evaluate the degree of RAS by angiography at the end of the operation
The severity of RAS was classified as severe, moderate, or mild based on the degree of stenosis observed on radial arteriography: greater than 75%, 25-75%, and less than 25% of the vessel diameter, respectively. In addition, if the combined spasm length exceeded 2cm, the severity increased by 1 grade.
Time frame: During the operation
Assess unfavorable RA for repeated trans-radial interventions (TRI) at 1 month after surgery by ultrasonography.
The the radial artery was evaluated at 1 month after surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.The radial artery was considered unfavorable for repeated-TRI if it exhibited any of the following criteria: total occlusion, intima-media thickness (IMT) ≥0.5 mm and diameter \<1.5mm, moderate and diffuse stenosis (\> 10 mm in length), or severe focal or diffuse stenosis (regardless of length).
Time frame: Month 1 after surgery
Record the incidence of intima-media thickness (IMT) ≥0.5 mm and diameter <1.5mm at 1 month after surgery by ultrasonography.
The incidence of intima-media thickness (IMT) ≥0.5 mm and diameter \<1.5mm as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Time frame: Month 1 after surgery
Record the incidence of radial artery occlusion at 1 month after surgery by ultrasonography.
The incidence of radial artery occlusion as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Time frame: Month 1 after surgery
Record the incidence of moderate and diffuse stenosis (> 10 mm in length) at 1 month after surgery by ultrasonography.
The incidence of moderate and diffuse stenosis (\> 10 mm in length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Time frame: Month 1 after surgery
Record the incidence of severe focal or diffuse stenosis (regardless of length) at 1 month after surgery by ultrasonography.
The incidence of severe focal or diffuse stenosis (regardless of length) as a component of unfavorable RA for repeated TRI was recorded at one month follow-up.
Time frame: Month 1 after surgery
Record the use of nitroglycerin during the operation
When the radial sheath was inserted, upper limb angiography was performed, and nitroglycerin 200ug was administered if any degree of vasospasm in the upper limb was observed on the angiography. The administration of nitroglycerin in each group was recorded.
Time frame: During the operation
Record the incidence of intraoperative hypotension
The definition of intraoperative hypotension was a mean arterial blood pressure below 60mmHg.
Time frame: During the operation
Record physician satisfaction by questionnaire
Physician satisfaction was scored on a scale of 1-10, with a score of 1 indicating very poor and dissatisfied experience and a score of 10 indicating very satisfied. The surgeons were asked to fill in the satisfaction questionnaire according to the operation situation after operation and recorded.
Time frame: Day 0 after the surgery
Record the duration of radial artery puncture
The time from the beginning of the radial artery puncture to the placement of the radial sheath was recorded.
Time frame: At the begining of the operation
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 30min after BPB or control interventions
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 24h after surgery
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of radial artery by ultrasound 1 month after surgery
The radial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: Month 1 after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 30min after BPB or control interventions
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 24h after surgery
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of ulnar artery by ultrasound 1 month after surgery
The ulnar artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: Month 1 after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 30min after BPB or control interventions
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 30min after BPB or control interventions
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 24h after surgery
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: 24h after surgery
Measured diameter and the hemodynamic parameters of brachial artery by ultrasound 1 month after surgery
The brachial artery was evaluated(include diameter, PSV,EDV,TAMAX,PI,RI) before the surgery using ultrasonography by an anesthesiologist who was blinded to the group assignments.
Time frame: Month 1 after surgery
Record mean arterial pressure at different time points
The mean intraoperative arterial pressure from T0 to T8 was recorded. T0 indicates time after entering the operating room; T1,30 minutes after BPB or control procedure; T2, 5 minutes after induction of general anesthesia; T3, angiography after the radial sheath enters the radial artery; T4,1minutes after angiography; T5, 3minutes after angiography; T6, 5minutes after angiography; T7, 10 minutes after angiography; T8, completion of the operation.
Time frame: During the operation
Record perioperative complications
Perioperative complications include puncture site complications, brachial plexus complications, and other cardiovascular and cerebrovascular complications
Time frame: Day 1 after the surgery
Recorded the levels of eight inflammatory factors
The hospital laboratory conducted an examination on 8 inflammatory factors (include IL-2,IL-4,IL-6,IL-10,IL-17,IL-12P70,IFN-r,TNF-a) to assess postoperative infection, and subsequently provided the results.
Time frame: Day 1 after the surgery
Recorded the incidence of postoperative acute embolism events
A head magnetic resonance imaging(MRI) was conducted to document the occurrence of postoperative embolic events, such as acute cerebral infarction.
Time frame: Day 1 after the surgery
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