search
Back to results

Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
propofol, bupivacaine
sevoflurane, rocuronium
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Thoracoscopy, Recovery, Tracheal intubation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: older than 20 years old;
  • Tumor size less than 6 cm;
  • Eligible for unilateral thoracoscopic surgery;
  • Preoperative lung function FEV1 > 60%.

Exclusion Criteria:

  • 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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nonintubated group

Intubated group

Arm Description

Patients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine.

Patients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.
Changes of inflammatory cytokines before and after surgery.
Inflammatory responses

Full Information

First Posted
March 8, 2015
Last Updated
July 1, 2015
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02393664
Brief Title
Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection
Official Title
Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Thoracoscopy, Recovery, Tracheal intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nonintubated group
Arm Type
Experimental
Arm Description
Patients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine.
Arm Title
Intubated group
Arm Type
Active Comparator
Arm Description
Patients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium.
Intervention Type
Drug
Intervention Name(s)
propofol, bupivacaine
Other Intervention Name(s)
Fresofol, Marcaine
Intervention Description
Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.
Intervention Type
Drug
Intervention Name(s)
sevoflurane, rocuronium
Other Intervention Name(s)
Ultane, Esmeron
Intervention Description
Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.
Primary Outcome Measure Information:
Title
Postoperative Quality of Recovery Scale (PQRS)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.
Time Frame
1 month
Title
Changes of inflammatory cytokines before and after surgery.
Description
Inflammatory responses
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: older than 20 years old; Tumor size less than 6 cm; Eligible for unilateral thoracoscopic surgery; Preoperative lung function FEV1 > 60%. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Hui Hung, MD, MSc
Phone
886-2-23123456
Ext
62158
Email
hung.minghui@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Jung Cheng, MD, PhD
Phone
886-2-23123456
Ext
65517
Email
chengyj@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Phone
02-23123456
Ext
65178
Email
chenjs@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection

We'll reach out to this number within 24 hrs