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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | sole Thoracic Epidural Anesthesia |
|
| Group B | Active Comparator | General Anesthesia with One Lung Ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with expected difficult airway management.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | 1156 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22934136 | Background | 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. | |
| 26984963 | 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. |
| Label | URL |
|---|---|
| May awake video-assisted thoracoscopic surgery with thoracic epidural anesthesia use routinely for minimaly invasive thoracic surgery procedures in the future? | View source |
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all IPD that underlie results in a publication
starting 6 months after publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 |
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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.
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|
| 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). |
|
| Postoperative opioid needs | Pethidine consumption | Postoperatively during the 24 hours after regaining sensation |
| Hospital stay | from day of operation to discharge; average, 5 days |
| 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 |
| 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 |
| Number of episodes of Post Operative Nausea and Vomiting (PONV) | During the 24 hours postoperatively |
| Perioperative changes in mean arterial pressure | mean arterial pressure (MAP) in mmHg | Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours |
| 15511470 | 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. |
| 25815298 | 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. |
| Sep 30, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2019 | Sep 30, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| D000086002 | Mesothelioma, Malignant |
| D016724 | Empyema, Pleural |
| D008171 | Lung Diseases |
| D010997 | Pleural Neoplasms |
| D001261 | Pulmonary Atelectasis |
| D010995 | Pleural Diseases |
| D010490 | Pericardial Effusion |
| D011030 | Pneumothorax |
| D006491 | Hemothorax |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D012140 | Respiratory Tract Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D061810 | One-Lung Ventilation |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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