A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia (VATS)

Mohamed Reda Ashour

Status and phase: Unknown; Phase 4

Conditions: Pericardial Effusion; Pulmonary Diseases or Conditions; Pleural Mesothelioma; Mediastinal Lymphadenopathy; Pulmonary Atelectasis; Hemothorax; Pleural Diseases; Pleural Neoplasms; Pneumothorax and Air Leak; Pleural Effusion, Malignant; Pyopneumothorax; Pleural Empyema

Treatments: Procedure: Thoracic Epidural Anesthesia; Procedure: General Anesthesia with One Lung Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05077111

FMASU M D 389/2019

Details and patient eligibility

About

Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and single lung ventilation. However, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.

Full description

The aim of this study is to investigate the feasibility and the effect of Thoracic Epidural Anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying General Anesthesia with one lung ventilation.

Type of Study: Prospective randomized clinical study. Study Setting: This study will be conducted in Ain Shams University Hospitals..

Study Period: Expected for two years starting from 2019.

Sampling Method: Randomized sampling by a computer generated random numbers table.

Sample Size: 40 patients. Sample size was calculated using PASS 11 program for sample size calculation and according to the (Pompeo et al., 2004) study, the mean PaO2 perioperatively in the awake group = -3±1.5 mmHg and in the second group = -6.5±1.83 mmHg. Sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA less than or equal II.
• The procedure expected to be completed within 2 hours.

Exclusion criteria

• Patients with expected difficult airway management.

  • Hemodynamically unstable patients.
  • Persistent cough or high airway secretions.
  • Severe Emphysema or clinical signs of active infectious disease.
  • Hypoxemia (PaO2 <60 mmHg) or hypercarbia (PCO2 >50 mmHg)
  • Coagulopathy (INR >1.5).
  • Obesity (BMI >30 Kg/m 2 ).
  • Infection at the injection site, allergy to local anesthetics.
  • Neurological disorders: seizures, intracranial mass or brain edema.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Experimental group

Description:

sole Thoracic Epidural Anesthesia

Treatment:

Procedure: Thoracic Epidural Anesthesia

Group B

Active Comparator group

Description:

General Anesthesia with One Lung Ventilation

Treatment:

Procedure: General Anesthesia with One Lung Ventilation