Spots Global Cancer Trial Database for A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
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Trial Identification
Brief Title: A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
Official Title: A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation
Study ID: NCT05077111
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.
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.
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Ain Shams University, Cairo, , Egypt
Contact Details
Name: Samia A M Abdel Latif, Professor
Affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Role: STUDY_CHAIR
Name: Waleed El Taher, Professor
Affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Role: STUDY_DIRECTOR
Name: Hany H El Sayed, Professor
Affiliation: Department of Thoracic Surgery, Ain Shams University.
Role: STUDY_DIRECTOR
Name: Ahmed F Koraitim, MD
Affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Role: STUDY_DIRECTOR
Name: Mohamed A A alhadidy, MD
Affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Role: STUDY_DIRECTOR
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