A Phase 4 interventional study of Thoracic Epidural Anesthesia and General Anesthesia with One Lung Ventilation in Pleural Effusion, Malignant, Pleural Mesothelioma and Pleural Empyema, sponsored by Mohamed Reda Ashour. Status unknown at 1 site in Egypt. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by Mohamed Reda Ashour · Phase 4, Interventional, and Supportive care
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.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →This is the only study on the registry with Mohamed Reda Ashour as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with expected difficult airway management.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
sole Thoracic Epidural Anesthesia
Procedure: Thoracic Epidural Anesthesia
General Anesthesia with One Lung Ventilation
Procedure: General Anesthesia with One Lung Ventilation
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 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).
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.
Time frame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours
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.
Time frame: Postoperatively at 3,12 and 24 hours
Postoperative opioid needs
Pethidine consumption
Time frame: Postoperatively during the 24 hours after regaining sensation
Hospital stay
Time frame: from day of operation to discharge; average, 5 days
Perioperative changes in heart rate
heart rate (HR) in beats per minute (bpm)
Time frame: 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.
Time frame: During the 24 hours after regaining of full motor power
Number of episodes of Post Operative Nausea and Vomiting (PONV)
Time frame: During the 24 hours postoperatively
Perioperative changes in mean arterial pressure
mean arterial pressure (MAP) in mmHg
Time frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: starting 6 months after publication
Ran from Jan 2020 to primary completion in Sep 2021, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.