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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03302221
• Other study ID #: 20170711-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 15, 2017
• Est. completion date: September 20, 2020

Study information

• Verified date: March 2020
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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
• 0.25% ropivacaine epidural block
A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.
• 0.5% ropivacaine local anaesthesia
local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	intraoperative consumption of phenylephrine	intraoperative consumption of phenylephrine	through study completion, an average of 3 hours