Pleural Effusion, MalignantPhase 4VATSNCT05077111

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

A Phase 4 study testing Thoracic Epidural Anesthesia and General Anesthesia with One Lung Ventilation in people with Pleural Effusion, Malignant and Pleural Mesothelioma, run by Mohamed Reda Ashour at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pleural Effusion, Malignant, Pleural Mesothelioma, Pleural Empyema
What is being tested?: Thoracic Epidural Anesthesia and General Anesthesia with One Lung Ventilation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 15 Jan 2020to 15 Oct 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Show all 9Show fewer

Obesity (BMI \>30 Kg/m 2 ).
Infection at the injection site, allergy to local anesthetics.
Neurological disorders: seizures, intracranial mass or brain edema.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University
Cairo, 1156

Other trials in Egypt

About this study

Official title: A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation

Read the 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.

Conditions: Pleural Effusion, Malignant, Pleural Mesothelioma, Pleural Empyema, Pulmonary Diseases or Conditions, Pleural Neoplasms, Pulmonary Atelectasis
Being tested: Thoracic Epidural Anesthesia, General Anesthesia with One Lung Ventilation
Keywords: thoracocentesis,, pleural, biopsy, wash, effusion,, ventilation, thoracic epidural, non intubated VATS,, pericardiocenthesis
Medical subject headings: Pleural Effusion, Malignant, Mesothelioma, Malignant, Empyema, Pleural, Lung Diseases, Pleural Neoplasms, Pulmonary Atelectasis, Pleural Diseases, Pericardial Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thoracic Epidural AnesthesiaProcedure or surgery
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 VentilationProcedure or surgery
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).

Study groups in NCT05077111
Study group	Role	What they receive
Group A	Experimental	sole Thoracic Epidural Anesthesia Receives: Procedure: Thoracic Epidural Anesthesia
Group B	Active comparator	General Anesthesia with One Lung Ventilation Receives: Procedure: General Anesthesia with One Lung Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours

Secondary outcomes (7)

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.
Measured: Postoperatively at 3,12 and 24 hours
Postoperative opioid needs
Pethidine consumption
Measured: Postoperatively during the 24 hours after regaining sensation
Hospital stay
Measured: from day of operation to discharge; average, 5 days
Perioperative changes in heart rate
heart rate (HR) in beats per minute (bpm)
Measured: 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.
Measured: During the 24 hours after regaining of full motor power
Number of episodes of Post Operative Nausea and Vomiting (PONV)
Measured: During the 24 hours postoperatively
Perioperative changes in mean arterial pressure
mean arterial pressure (MAP) in mmHg
Measured: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202015 Oct 2021

First posted14 Oct 2021
Study start15 Jan 2020
Primary completion15 Sep 2021
Study completion15 Oct 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05077111
Sponsor's protocol ID: FMASU M D 389/2019
Acronym: VATS
Status last verified: Sep 2021
First submitted: 19 Sep 2021
Last updated: 14 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: all IPD that underlie results in a publication

Publications

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.
PubMed 22934136
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.
PubMed 26984963
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.
PubMed 15511470
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.
PubMed 25815298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
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Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
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All Pleural Effusion, Malignant trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation
ClinicalTrials.gov ID: NCT05077111
Acronym / sponsor ID: VATS / FMASU M D 389/2019
Conditions: Pleural Effusion, Malignant, Pleural Mesothelioma, Pleural Empyema, Pulmonary Diseases or Conditions, Pleural Neoplasms, Pulmonary Atelectasis
Keywords: thoracocentesis,, pleural, biopsy, wash, effusion,, ventilation, thoracic epidural, non intubated VATS,, pericardiocenthesis
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Mohamed Reda AshourUniversity, hospital or other
Study start: 15 Jan 2020 (actual)
Primary completion: 15 Sep 2021 (actual)
Study completion: 15 Oct 2021 (estimated)
First posted: 14 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group A	Experimental	Procedure: Thoracic Epidural Anesthesiasole Thoracic Epidural Anesthesia
Group B	Active comparator	Procedure: General Anesthesia with One Lung VentilationGeneral Anesthesia with One Lung Ventilation

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

Patients with expected difficult airway management.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thoracic Epidural AnesthesiaGroup 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.	Procedure or surgery	Group A
General Anesthesia with One Lung VentilationGroup 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).	Procedure or surgery	Group B

Primary outcome

Perioperative changes in blood gases
Time frame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours
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.

7 secondary outcomes

Postoperative pain
Time frame: Postoperatively at 3,12 and 24 hours
Postoperative opioid needs
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
Time frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours
The onset of ambulance.
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
Time frame: Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Background: PubMed 22934136Chen 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.
Background: PubMed 26984963Deng 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.
Background: PubMed 15511470Pompeo 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.
Background: PubMed 25815298Pompeo 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.
May awake video-assisted thoracoscopic surgery with thoracic epidural anesthesia use routinely for minimaly invasive thoracic surgery procedures in the future?Link provided by the sponsor.
Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication

Related trials for Pleural Effusion, Malignant

RecruitingObservational study
UNC Pleural Fluid Registry
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Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samia A M Abdel Latif, Professor study chair

Department of Anesthesia, Intensive care and pain management, Ain Shams University.

Waleed El Taher, Professor study director

Department of Anesthesia, Intensive care and pain management, Ain Shams University.

Hany H El Sayed, Professor study director

Department of Thoracic Surgery, Ain Shams University.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative changes in blood gases (time frame: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077111, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.