Clinical trial NCT05077111: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pleural Effusion, Malignant
Pleural Mesothelioma
Pleural Empyema
Pulmonary Diseases or Conditions
Pleural Neoplasms
Pulmonary Atelectasis
Pleural Diseases
Pericardial Effusion
Mediastinal Lymphadenopathy
Pneumothorax and Air Leak
Hemothorax
Pyopneumothorax
Keywords: thoracocentesis,
pleural, biopsy, wash, effusion,
ventilation
thoracic epidural
non intubated VATS,
pericardiocenthesis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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 criteria: Inclusion Criteria:

* ASA less than or equal II.
* The procedure expected to be completed within 2 hours.

Exclusion Criteria:

* Patients with expected difficult airway management.

  * Hemodynamically unstable patients.
  * Persistent cough or high airway secretions.
  * Severe Emphysema or clinical signs of active infectious disease.
  * Hypoxemia (PaO2 \&lt;60 mmHg) or hypercarbia (PCO2 \&gt;50 mmHg)
  * Coagulopathy (INR \&gt;1.5).
  * Obesity (BMI \&gt;30 Kg/m 2 ).
  * Infection at the injection site, allergy to local anesthetics.
  * Neurological disorders: seizures, intracranial mass or brain edema.

Primary outcomes:
measure: Perioperative changes in blood gases
timeFrame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: Postoperatively at 3,12 and 24 hours
measure: Postoperative opioid needs
timeFrame: Postoperatively during the 24 hours after regaining sensation
measure: Hospital stay
timeFrame: from day of operation to discharge; average, 5 days
measure: Perioperative changes in heart rate
timeFrame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
measure: The onset of ambulance.
timeFrame: During the 24 hours after regaining of full motor power
measure: Number of episodes of Post Operative Nausea and Vomiting (PONV)
timeFrame: During the 24 hours postoperatively
measure: Perioperative changes in mean arterial pressure
timeFrame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Samia A M Abdel Latif, Professor
role: STUDY_CHAIR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Waleed El Taher, Professor
role: STUDY_DIRECTOR
affiliation: Department of Thoracic Surgery, Ain Shams University.
name: Hany H El Sayed, Professor
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Ahmed F Koraitim, MD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Mohamed A A alhadidy, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.