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

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.

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

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).

Sponsors & Collaborators

• Mohamed Reda Ashour

  lead OTHER

Principal Investigators

• Samia A M Abdel Latif, Professor · Department of Anesthesia, Intensive care and pain management, Ain Shams University.

• Waleed El Taher, Professor · Department of Anesthesia, Intensive care and pain management, Ain Shams University.

• Hany H El Sayed, Professor · Department of Thoracic Surgery, Ain Shams University.

• Ahmed F Koraitim, MD · Department of Anesthesia, Intensive care and pain management, Ain Shams University.

• Mohamed A A alhadidy, MD · Department of Anesthesia, Intensive care and pain management, Ain Shams University.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-15

Primary Completion

2021-09-15

Completion

2021-10-15

Countries

• Egypt

Study Locations