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Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

U

University of Turin

Status

Completed

Conditions

Diaphragm Issues
Thoracic Surgery
Regional Anesthesia
Ultrasounds

Treatments

Procedure: Regional awake anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT04700943
DULORATHO

Details and patient eligibility

About

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

Full description

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome.

However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

The investigators divided our population into two groups: one group of patients undergoing awake thoracic surgery with epidural anesthesia, and the other group undergoing general anesthesia.

Forty-one patients were recruited and the Thickening Fraction percentage, calculated as (End Inspiratory thickness-End Expiratory thickness)/End Expiratory thickness, was evaluated by means of an ultrasound-assisted method, using a high frequency (10 MHz) linear probe.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for lung biopsy from February 2019 to September 2020

Exclusion criteria

  • pregnancy,
  • Body Mass Index >35,
  • Inability to provide informed consent,
  • American Society of Anesthesiologists physical status classification score of IV
  • Recommended postoperative ICU care

Trial design

41 participants in 2 patient groups

Regional awake anesthesia
Description:
In non-intubated patients, an epidural catheter was placed at T5-T6. An anesthetic load of 0,5 mg/kg of ropivacaine was administered to reach anesthesia of the thoracic wall. Adjunctive local anesthetic infiltration of the incision site was performed by the surgeon with 2% lidocaine and 7,5% Ropivacaine. The cumulative dose of anesthetics drugs was computed as not to exceed the recommended dosage. To improve patient comfort through the procedure, sedation with Target Controlled Infusion of propofol (using Schnider algorithm) and low dose remifentanil (0,05 mcg/kg/min) was also administered.
Treatment:
Procedure: Regional awake anesthesia
General anesthesia
Description:
Either epidural block or an interfascial plane block of the thoracic wall, such as serratus anterior plane block or erector spinae plane block, were performed. Patients were then anesthetized with Propofol plus opiates (usually remifentanil) and muscle paralysis was achieved with Rocuronium.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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