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Clinical Trials/NCT03302221
NCT03302221
Withdrawn
Phase 4

Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management

China Medical University, China1 site in 1 countryOctober 15, 2017

Overview

Phase
Phase 4
Intervention
0.5% ropivacaine local anaesthesia
Conditions
Lung Cancer
Sponsor
China Medical University, China
Locations
1
Primary Endpoint
The Change of end-diastolic velocity
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2017
End Date
September 20, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wen-fei Tan

Associate proffesor

China Medical University, China

Eligibility Criteria

Inclusion Criteria

  • ethnic Chinese;
  • age, 18 to 65 years old;
  • American Society of Anaesthesiologists (ASA) physical status I or II;
  • 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

Arms & Interventions

Group control

In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.

Intervention: 0.5% ropivacaine local anaesthesia

Paravertebral Block Group

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.

Intervention: 0.5% ropivacaine paravertebral block

Epidural Block Group

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

Intervention: 0.25% ropivacaine epidural block

Outcomes

Primary Outcomes

The Change of end-diastolic velocity

Time Frame: 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 Outcomes

  • pulsed-wave Doppler ultrasound(before leaving the PACU, up to 5 minutes)
  • intraoperative consumption of phenylephrine(through study completion, an average of 3 hours)

Study Sites (1)

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