Lung NeoplasmsPhase 2/3NCT02393664
Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection
A Phase 2/3 study testing propofol, bupivacaine and sevoflurane, rocuronium in people with Lung Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- propofol, bupivacaine and sevoflurane, rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Oct 2016
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: older than 20 years old;
- Tumor size less than 6 cm;
- Eligible for unilateral thoracoscopic surgery;
- Preoperative lung function FEV1 > 60%.
Who cannot join
- Neurological deficits, including previous stroke, dementia etc.;
- Previous thoracic surgery;
- Suspect invasion of tumor into chest wall, diaphragm, or main bronchus;
- Suspect severe pleural or diaphragmatic adhesions;
- Significant comorbidities with high ASA classification (ASA > 3), including history of heart failure, liver failure and renal failure;
- Severe obstructive sleep apnea requiring continuous positive airway pressure support or oxygen supplement;
- Difficult airway management;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jin-Shing Chen, MD, PhD, 02-23123456 ext. 65178, chenjs@ntu.edu.tw
About this study
Official title: Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection: A Prospective Randomized Trial
Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally, current lung cancer screening policy recruits increasing number of candidates requiring thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an endobronchial blocker has been considered mandatory in thoracoscopic surgery. However, adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated thoracoscopic technique has developed to reduce the adverse effects of intubated general anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As an enhanced recovery is the major goal of modern minimally invasive surgery, the investigators hypothesize that nonintubated thoracoscopic technique can facilitate and improve the recovery quality after surgery. To this end, the investigators will recruit 300 patients in subgroups including patients undergoing segmentectomy/lobectomy, wedge resection and geriatric patients in this two-year project. Patients will be randomly allocated in nonintubated and intubated groups and quality of recovery of all patients will be evaluated according the protocol of Postoperative Quality of Recovery Scale. In the meantime, the preoperative and postoperative cytokines will be compared between the groups as well as patients with different recovery scales.
Read the detailed description
Treatment protocol of nonintubated technique and intubated general anesthesia
Nonintubated technique: All nonintubated patients will be premedicated with 50 to 100 μg of fentanyl intravenously and will be continuously monitored electrocardiographically, along with pulse oximetry, respiratory rate, blood pressure, body temperature, and urine output. End-tidal carbon dioxide will be continuously monitored by insertion of a detector into one nostril. A bispectral index sensor (BIS Quatro, Aspect Medical System, Norwood, MA, USA) will be applied to the forehead of each patient to monitor the level of consciousness. Additionally, a non-invasive near-infrared cerebral regional oximetry (INVOSTM 5100BINVOS 5100B Cerebral Oximeter, Somanetics Corporation, Troy, MI, USA) will be applied to monitor the regional oxygen saturation of the brains. The patients will be sedated with intravenous propofol (Fresol 1%, Fresenius Kabi GmbH, Graz, Austria) using a target-controlled infusion method (Injectomat® TIVA Agilia, Fresenius Kabi GmbH, Graz, Austria). The level of sedation will be set to achieve a bispectral index value between 40 and 60, and incremental intravenous injections of fentanyl 25 μg will be given to maintain a respiratory rate between 12 and 20 breaths/min. Oxygen will be supplied through a ventilation mask.
Conventional intubated general anesthesia: All intubated patients will be monitored as for nonintubated patients. Anesthesia will be induced by intravenous administration of propofol (1 - 2.5 mg/kg), fentanyl (100 μg), and rocuronium (0.6 mg/kg) and will be maintained by sevoflurane and rocuronium at the discretion of anesthesiologist and bispectral index monitoring. A double-lumen endotracheal tube or endobronchial blocker will be inserted for one lung isolation during the procedure and a bronchoscopy will be used to facilitate the correct isolation of targeted bronchus at the discretion of anesthesiologist. The dependent lung will be ventilated using protective lung strategy with a tidal volume of 6 to 8 mL/kg, a respiratory rate of 10 to 16 breaths/min to maintain the arterial carbon dioxide tension at 35 to 45 mmHg. After the operation, the patients will be extubated in the operating room or remain intubated and be sent to the intensive care unit at the discretion of anesthesiologist.
- Conditions
- Lung Neoplasms
- Being tested
- propofol, bupivacaine, sevoflurane, rocuronium
- Keywords
- Thoracoscopy, Recovery, Tracheal intubation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, bupivacaineDrug
Also called Fresofol, Marcaine
Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.
sevoflurane, rocuroniumDrug
Also called Ultane, Esmeron
Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.
| Study group | Role | What they receive |
|---|---|---|
| Nonintubated group | Experimental | Patients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine. Receives: Drug: propofol, bupivacaine |
| Intubated group | Active comparator | Patients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium. Receives: Drug: sevoflurane, rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery Scale (PQRS)
PQRS is a measure tool to evaluate the patient recovery after surgery, which includes five domains, i.e., physiological factors, nociceptive factors, emotional factors, recovery of activity of daily life and cognitive factors.
Measured: 1 month
Secondary outcomes (2)
Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.
Measured: 1 month
Changes of inflammatory cytokines before and after surgery.
Inflammatory responses
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393664
- Sponsor's protocol ID
- 201410045RINB
- Status last verified
- Jul 2015
- First submitted
- 8 Mar 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02393664
- Acronym / sponsor ID
- 201410045RINB
- Conditions
- Lung Neoplasms
- Keywords
- Thoracoscopy, Recovery, Tracheal intubation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- 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.
Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally, current lung cancer screening policy recruits increasing number of candidates requiring thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an endobronchial blocker has been considered mandatory in thoracoscopic surgery. However, adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated thoracoscopic technique has developed to reduce the adverse effects of intubated general anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As an enhanced recovery is the major goal of modern minimally invasive surgery, the investigators hypothesize that nonintubated thoracoscopic technique can facilitate and improve the recovery quality after surgery. To this end, the investigators will recruit 300 patients in subgroups including patients undergoing segmentectomy/lobectomy, wedge resection and geriatric patients in this two-year project. Patients will be randomly allocated in nonintubated and intubated groups and quality of recovery of all patients will be evaluated according the protocol of Postoperative Quality of Recovery Scale. In the meantime, the preoperative and postoperative cytokines will be compared between the groups as well as patients with different recovery scales.
Detailed description
Treatment protocol of nonintubated technique and intubated general anesthesia
Nonintubated technique: All nonintubated patients will be premedicated with 50 to 100 μg of fentanyl intravenously and will be continuously monitored electrocardiographically, along with pulse oximetry, respiratory rate, blood pressure, body temperature, and urine output. End-tidal carbon dioxide will be continuously monitored by insertion of a detector into one nostril. A bispectral index sensor (BIS Quatro, Aspect Medical System, Norwood, MA, USA) will be applied to the forehead of each patient to monitor the level of consciousness. Additionally, a non-invasive near-infrared cerebral regional oximetry (INVOSTM 5100BINVOS 5100B Cerebral Oximeter, Somanetics Corporation, Troy, MI, USA) will be applied to monitor the regional oxygen saturation of the brains. The patients will be sedated with intravenous propofol (Fresol 1%, Fresenius Kabi GmbH, Graz, Austria) using a target-controlled infusion method (Injectomat® TIVA Agilia, Fresenius Kabi GmbH, Graz, Austria). The level of sedation will be set to achieve a bispectral index value between 40 and 60, and incremental intravenous injections of fentanyl 25 μg will be given to maintain a respiratory rate between 12 and 20 breaths/min. Oxygen will be supplied through a ventilation mask.
Conventional intubated general anesthesia: All intubated patients will be monitored as for nonintubated patients. Anesthesia will be induced by intravenous administration of propofol (1 - 2.5 mg/kg), fentanyl (100 μg), and rocuronium (0.6 mg/kg) and will be maintained by sevoflurane and rocuronium at the discretion of anesthesiologist and bispectral index monitoring. A double-lumen endotracheal tube or endobronchial blocker will be inserted for one lung isolation during the procedure and a bronchoscopy will be used to facilitate the correct isolation of targeted bronchus at the discretion of anesthesiologist. The dependent lung will be ventilated using protective lung strategy with a tidal volume of 6 to 8 mL/kg, a respiratory rate of 10 to 16 breaths/min to maintain the arterial carbon dioxide tension at 35 to 45 mmHg. After the operation, the patients will be extubated in the operating room or remain intubated and be sent to the intensive care unit at the discretion of anesthesiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonintubated group | Experimental | Drug: propofol, bupivacainePatients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine. |
| Intubated group | Active comparator | Drug: sevoflurane, rocuroniumPatients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: older than 20 years old;
- Tumor size less than 6 cm;
- Eligible for unilateral thoracoscopic surgery;
- Preoperative lung function FEV1 > 60%.
Key exclusion criteria (8 listed)
- Neurological deficits, including previous stroke, dementia etc.;
- Previous thoracic surgery;
- Suspect invasion of tumor into chest wall, diaphragm, or main bronchus;
- Suspect severe pleural or diaphragmatic adhesions;
- Significant comorbidities with high ASA classification (ASA > 3), including history of heart failure, liver failure and renal failure;
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 |
|---|---|---|
| propofol, bupivacaineAlso: Fresofol, MarcaineNonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations. | Drug | Nonintubated group |
| sevoflurane, rocuroniumAlso: Ultane, EsmeronConventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker. | Drug | Intubated group |
Primary outcome
Postoperative Quality of Recovery Scale (PQRS)
Time frame: 1 month
PQRS is a measure tool to evaluate the patient recovery after surgery, which includes five domains, i.e., physiological factors, nociceptive factors, emotional factors, recovery of activity of daily life and cognitive factors.
2 secondary outcomes
Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.
Time frame: 1 month
Changes of inflammatory cytokines before and after surgery.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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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.
Jin-Shing Chen, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing propofol, bupivacaine and sevoflurane, rocuronium in people with Lung Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 8 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 3 Jul 2015. 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 Taiwan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ming-Hui Hung, MD, MSc (886-2-23123456 ext. 62158, hung.minghui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery Scale (PQRS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2015.