Hemothorax, Mediastinal Lymphadenopathy, Pericardial Effusion, Pleural Diseases, Pleural Effusion, Malignant, Pleural Empyema, Pleural Mesothelioma, Pleural Neoplasms, Pneumothorax and Air Leak, Pulmonary Atelectasis, Pulmonary Diseases or Conditions, Pyopneumothorax
Conditions
Keywords
thoracocentesis,, pleural, biopsy, wash, effusion,, ventilation, thoracic epidural, non intubated VATS,, pericardiocenthesis
Brief summary
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
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.
Interventions
PROCEDUREThoracic Epidural Anesthesia
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.
PROCEDUREGeneral Anesthesia with One Lung Ventilation
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).
Sponsors
Mohamed Reda Ashour
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative changes in blood gases | Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours | 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) < 92% on room air with a need for oxygen supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid needs | Postoperatively during the 24 hours after regaining sensation | Pethidine consumption |
| Hospital stay | from day of operation to discharge; average, 5 days | — |
| Perioperative changes in heart rate | Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours | heart rate (HR) in beats per minute (bpm) |
| Postoperative pain | Postoperatively at 3,12 and 24 hours | 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. |
| Number of episodes of Post Operative Nausea and Vomiting (PONV) | During the 24 hours postoperatively | — |
| Perioperative changes in mean arterial pressure | Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours | mean arterial pressure (MAP) in mmHg |
| The onset of ambulance. | During the 24 hours after regaining of full motor power | Rate of occurence of falling after ambulance will be recorded in each group. |
Countries
Egypt
Outcome results
None listed