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

NCT ID: NCT03302221

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2020-09-20

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group control

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

Group Type: OTHER

0.5% ropivacaine local anaesthesia

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

0.5% ropivacaine paravertebral block

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

0.25% ropivacaine epidural block

Intervention Type: DRUG

A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.

Interventions

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

Intervention Type: DRUG

0.25% ropivacaine epidural block

A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.

Intervention Type: DRUG

0.5% ropivacaine local anaesthesia

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Wen-fei Tan

Associate proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Ma, MD,PhD

Role: STUDY_CHAIR

Department of Anesthesiology

Locations

the First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

20170711-01

Identifier Type: -

Identifier Source: org_study_id