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

Pulmonary Atelectasis Clinical Trial

— VATS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05077111
• Other study ID #: FMASU M D 389/2019
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 15, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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).

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Reda Ashour

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative opioid needs	Pethidine consumption	Postoperatively during the 24 hours after regaining sensation
Secondary	Hospital stay		from day of operation to discharge; average, 5 days
Secondary	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
Secondary	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
Secondary	Number of episodes of Post Operative Nausea and Vomiting (PONV)		During the 24 hours postoperatively
Secondary	Perioperative changes in mean arterial pressure	mean arterial pressure (MAP) in mmHg	Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

External Links

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