VATS: A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A sole Thoracic Epidural Anesthesia |
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.
|
| Active Comparator: Group B General Anesthesia with One Lung Ventilation |
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).
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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)
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA less than or equal II.
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The procedure expected to be completed within 2 hours.
Exclusion Criteria:
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Patients with expected difficult airway management.
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Hemodynamically unstable patients.
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Persistent cough or high airway secretions.
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Severe Emphysema or clinical signs of active infectious disease.
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Hypoxemia (PaO2 <60 mmHg) or hypercarbia (PCO2 >50 mmHg)
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Coagulopathy (INR >1.5).
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Obesity (BMI >30 Kg/m 2 ).
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Infection at the injection site, allergy to local anesthetics.
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Neurological disorders: seizures, intracranial mass or brain edema.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams University | Cairo | Egypt | 1156 |
Sponsors and Collaborators
- Mohamed Reda Ashour
Investigators
- Study Chair: Samia A M Abdel Latif, Professor, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
- Study Director: 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 Documents (Full-Text)
More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- FMASU M D 389/2019