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A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia (VATS)

Primary Purpose

Pleural Effusion, Malignant, Pleural Mesothelioma, Pleural Empyema

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic Epidural Anesthesia
General Anesthesia with One Lung Ventilation
Sponsored by
Mohamed Reda Ashour
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pleural Effusion, Malignant focused on measuring thoracocentesis,, pleural, biopsy, wash, effusion,, ventilation, thoracic epidural, non intubated VATS,, pericardiocenthesis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 <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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

sole Thoracic Epidural Anesthesia

General Anesthesia with One Lung Ventilation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Postoperative opioid needs
Pethidine consumption
Hospital stay
Perioperative changes in heart rate
heart rate (HR) in beats per minute (bpm)
The onset of ambulance.
Rate of occurence of falling after ambulance will be recorded in each group.
Number of episodes of Post Operative Nausea and Vomiting (PONV)
Perioperative changes in mean arterial pressure
mean arterial pressure (MAP) in mmHg

Full Information

First Posted
September 19, 2021
Last Updated
September 30, 2021
Sponsor
Mohamed Reda Ashour
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1. Study Identification

Unique Protocol Identification Number
NCT05077111
Brief Title
A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
Acronym
VATS
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Reda Ashour

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
sole Thoracic Epidural Anesthesia
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
General Anesthesia with One Lung Ventilation
Intervention Type
Procedure
Intervention Name(s)
Thoracic Epidural Anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia with One Lung Ventilation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Perioperative changes in blood gases
Description
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
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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
Title
Postoperative opioid needs
Description
Pethidine consumption
Time Frame
Postoperatively during the 24 hours after regaining sensation
Title
Hospital stay
Time Frame
from day of operation to discharge; average, 5 days
Title
Perioperative changes in heart rate
Description
heart rate (HR) in beats per minute (bpm)
Time Frame
Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
Title
The onset of ambulance.
Description
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
Title
Number of episodes of Post Operative Nausea and Vomiting (PONV)
Time Frame
During the 24 hours postoperatively
Title
Perioperative changes in mean arterial pressure
Description
mean arterial pressure (MAP) in mmHg
Time Frame
Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia A M Abdel Latif, Professor
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Waleed El Taher, Professor
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hany H El Sayed, Professor
Organizational Affiliation
Department of Thoracic Surgery, Ain Shams University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed F Koraitim, MD
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A A alhadidy, MD
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
1156
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
22934136
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.
Results Reference
background
PubMed Identifier
26984963
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.
Results Reference
background
PubMed Identifier
15511470
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.
Results Reference
background
PubMed Identifier
25815298
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.
Results Reference
background
Links:
URL
https://www.ijsurgery.com/index.php/isj/article/view/2746
Description
May awake video-assisted thoracoscopic surgery with thoracic epidural anesthesia use routinely for minimaly invasive thoracic surgery procedures in the future?

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A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia

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