NCT05077111

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mohamed Reda Ashour · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• 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
• Hemothorax
• Pyopneumothorax

Interventions

Type	Name	Description
PROCEDURE	Thoracic 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.
PROCEDURE	General 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).

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-09-15
• Completion: 2021-10-15
• First posted: 2021-10-14
• Last updated: 2021-10-14

Locations

1 site across 1 country: Egypt