Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound

Phase 4

Withdrawn

• Conditions: Lung Cancer
• Interventions: Drug: 0.5% ropivacaine paravertebral block; Drug: 0.5% ropivacaine local anaesthesia; Drug: 0.25% ropivacaine epidural block

• Registration Number: NCT03302221
• Lead Sponsor: China Medical University, China

Brief Summary

The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.

Detailed Description

The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. The patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. Velocity-associated data related to pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.

Study Timeline

• Study First Submitted: 2017-10-01
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Study Start: 2017-10-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-08-20
• Study Completion: 2020-09-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. ethnic Chinese;
2. age, 18 to 65 years old;
3. American Society of Anaesthesiologists (ASA) physical status I or II;
4. required VATS for lung surgery and one lung ventilation .

Exclusion Criteria

body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.

Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.

Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral Block Group	0.5% ropivacaine paravertebral block	In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre.
Group control	0.5% ropivacaine local anaesthesia	In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
Epidural Block Group	0.25% ropivacaine epidural block	The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block

Primary Outcome Measures

Name	Time	Method
The Change of end-diastolic velocity	baseline and 10 minutes after induction	The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.

Secondary Outcome Measures

Name	Time	Method
pulsed-wave Doppler ultrasound	before leaving the PACU, up to 5 minutes	other data related to pulsed-wave Doppler ultrasound and acquired during anaesthesia induction, before leaving the PACU and during inspiratory cough
intraoperative consumption of phenylephrine	through study completion, an average of 3 hours	intraoperative consumption of phenylephrine

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China