A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
NCT ID: NCT05077111
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2020-01-15
2021-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A
sole Thoracic Epidural Anesthesia
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.
Group B
General Anesthesia with One Lung Ventilation
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* The procedure expected to be completed within 2 hours.
Exclusion Criteria
* 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.
21 Years
65 Years
ALL
Yes
Sponsors
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Mohamed Reda Ashour
OTHER
Responsible Party
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Mohamed Reda Ashour
Assistant lecturer, Dept of Anesthesia, Intensive Care and Pain Management
Principal Investigators
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Samia A M Abdel Latif, Professor
Role: STUDY_CHAIR
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Waleed El Taher, Professor
Role: STUDY_DIRECTOR
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Hany H El Sayed, Professor
Role: STUDY_DIRECTOR
Department of Thoracic Surgery, Ain Shams University.
Ahmed F Koraitim, MD
Role: STUDY_DIRECTOR
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Mohamed A A alhadidy, MD
Role: STUDY_DIRECTOR
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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May awake video-assisted thoracoscopic surgery with thoracic epidural anesthesia use routinely for minimaly invasive thoracic surgery procedures in the future?
Other Identifiers
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FMASU M D 389/2019
Identifier Type: -
Identifier Source: org_study_id