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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: 0.5% ropivacaine local anaesthesia; Drug: 0.5% ropivacaine paravertebral block; Drug: 0.25% ropivacaine epidural block

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group control; In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.	Drug: 0.5% ropivacaine local anaesthesia; local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
Experimental: 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.	Drug: 0.5% ropivacaine paravertebral block; The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block
Experimental: 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	Drug: 0.25% ropivacaine epidural block; A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Medical University, China
• Investigators: Study Chair: Hong Ma, MD,PhD, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Anticipated): August 20, 2020
• Study Completion (Anticipated): September 20, 2020

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 20170711-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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