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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation

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

Intervention / Treatment
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* Procedure: Thoracic Epidural Anesthesia
* Procedure: General Anesthesia with One Lung Ventilation


Participation Criteria
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Eligibility Criteria
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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 &lt;60 mmHg) or hypercarbia (PCO2 &gt;50 mmHg) Coagulopathy (INR &gt;1.5). Obesity (BMI &gt;30 Kg/m 2 ). Infection at the injection site, allergy to local anesthetics. Neurological disorders: seizures, intracranial mass or brain edema.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the study will include 40 participants, randomized into 2 equal groups, Group A: Awake participants will receive sole Thoracic Epidural Anesthesia. Group B: Participants receiving General Anesthesia with One Lung Ventilation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>sole Thoracic Epidural Anesthesia | Procedure: Thoracic Epidural Anesthesia<br>* Group A pre-medicated once using Midazolam 3-4mg intravenous (IV) and Fentanyl 50mcg, placed in the setting position. Using a winged 18G (Gadge), 9cm length Tuohy Epidural needle, a 20G springwound closed tip epidural catheter be inserted between T3-T4. A test dose (5ml) 2% Lidocaine given, followed by 5-8 ml Bupivacaine 0.5% and 50mcg Fentanyl as a loading dose. Further top-up dose of 5 ml Bupivicaine 0.5% after 45 minutes.<br>|
| Active Comparator: Group B<br>General Anesthesia with One Lung Ventilation | Procedure: General Anesthesia with One Lung Ventilation<br>* Group B premedicated once by 3-4mg Midazolam IV, Ranitidine 50mg, Metoclopramide 10mg and Dexamethasone 4mg. Preoxygenation with 100% O2. Induction of anesthesia with Propofol (2mg/kg) and Fentanyl (1mcg/kg). Tracheal intubation by 37-39 Fr Double Lumen Endotracheal Tube insertion facilitated with Cisatracurium 0.1mg/kg. and confirmation of its position by Fiberoptic Bronchoscopy. Selective Lung Ventilation strategy can be performed through the endobroncheal tube of the non operated lung once needed. Anesthesia maintained with Isoflurane (1-2%) and Cisatracurium (0.05mg/kg per dose). Later, anesthesia discontinued and extubation after full neuromuscular recovery after reversal of muscle relaxant by Neostigmine (0.05mg/kg) and Atropine (0.02mg/kg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative changes in blood gases | Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2). Hypoxemia is defined as peripheral oxygen saturation (SpO2) &lt; 92% on room air with a need for oxygen supplementation. | Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The Visual Analogue Scale (VAS) consists of a 10 cm straight line with the endpoints defining extreme limits of no pain at all (0 cm) and pain as bad as it could be (10 cm). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 0 and the mark then defines the subject pain score. | Postoperatively at 3,12 and 24 hours | 
| Postoperative opioid needs | Pethidine consumption | Postoperatively during the 24 hours after regaining sensation | 
| Hospital stay |  | from day of operation to discharge; average, 5 days | 
| Perioperative changes in heart rate | heart rate (HR) in beats per minute (bpm) | Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours | 
| The onset of ambulance. | Rate of occurence of falling after ambulance will be recorded in each group. | During the 24 hours after regaining of full motor power | 
| Number of episodes of Post Operative Nausea and Vomiting (PONV) |  | During the 24 hours postoperatively | 
| Perioperative changes in mean arterial pressure | mean arterial pressure (MAP) in mmHg | Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracocentesis,, pleural, biopsy, wash, effusion,, ventilation, thoracic epidural, non intubated VATS,, pericardiocenthesis