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

NCT05077111 | Unknown Phase 4

• 1 other identifier: FMASU M D 389/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Keywords

thoracocentesis,; pleural, biopsy, wash, effusion,; ventilation; thoracic epidural; non intubated VATS,; pericardiocenthesis

Outcome Measures

Primary Outcomes (1)

• 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) \< 92% on room air with a need for oxygen supplementation.

  Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours

Secondary Outcomes (7)

• Postoperative pain

  Postoperatively at 3,12 and 24 hours

• Postoperative opioid needs

  Postoperatively during the 24 hours after regaining sensation

• 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

• The onset of ambulance.

  During the 24 hours after regaining of full motor power

Study Arms (2)

Group A

EXPERIMENTAL

sole Thoracic Epidural Anesthesia

Procedure: Thoracic Epidural Anesthesia

Group B

ACTIVE COMPARATOR

General Anesthesia with One Lung Ventilation

Procedure: General Anesthesia with One Lung Ventilation

Interventions

Thoracic Epidural Anesthesia PROCEDURE

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.

Group A

General Anesthesia with One Lung Ventilation PROCEDURE

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).

Group B

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Reda Ashour: lead

Study Sites (1)

Ain Shams University

Cairo, 1156, Egypt

Location

Related Publications (4)

• Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic lung resection: a 3-year experience with 285 cases in a single institution. J Thorac Dis. 2012 Aug;4(4):347-51. doi: 10.3978/j.issn.2072-1439.2012.08.07.

  PMID: 22934136 BACKGROUND

• Deng HY, Zhu ZJ, Wang YC, Wang WP, Ni PZ, Chen LQ. Non-intubated video-assisted thoracoscopic surgery under loco-regional anaesthesia for thoracic surgery: a meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Jul;23(1):31-40. doi: 10.1093/icvts/ivw055. Epub 2016 Mar 16.

  PMID: 26984963 BACKGROUND

• Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.

  PMID: 15511470 BACKGROUND

• Pompeo E, Sorge R, Akopov A, Congregado M, Grodzki T; ESTS Non-intubated Thoracic Surgery Working Group. Non-intubated thoracic surgery-A survey from the European Society of Thoracic Surgeons. Ann Transl Med. 2015 Mar;3(3):37. doi: 10.3978/j.issn.2305-5839.2015.01.34.

  PMID: 25815298 BACKGROUND

Related Links

• May awake video-assisted thoracoscopic surgery with thoracic epidural anesthesia use routinely for minimaly invasive thoracic surgery procedures in the future?

MeSH Terms

Conditions

Pleural Effusion, Malignant; Mesothelioma, Malignant; Empyema, Pleural; Lung Diseases; Pleural Neoplasms; Pulmonary Atelectasis; Pleural Diseases; Pericardial Effusion; Pneumothorax; Hemothorax; Respiratory Aspiration

Interventions

Anesthesia, General; One-Lung Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Infections; Infections; Empyema; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Hemorrhage; Respiration Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Samia A M Abdel Latif, Professor

  Department of Anesthesia, Intensive care and pain management, Ain Shams University.

  STUDY CHAIR

• Waleed El Taher, Professor

  Department of Anesthesia, Intensive care and pain management, Ain Shams University.

  STUDY DIRECTOR

• Hany H El Sayed, Professor

  Department of Thoracic Surgery, Ain Shams University.

  STUDY DIRECTOR

• Ahmed F Koraitim, MD

  Department of Anesthesia, Intensive care and pain management, Ain Shams University.

  STUDY DIRECTOR

• Mohamed A A alhadidy, MD

  Department of Anesthesia, Intensive care and pain management, Ain Shams University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer, Dept of Anesthesia, Intensive Care and Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 14, 2021
• Study Start: January 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication

Locations

EG (1)