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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms
• Intervention / Treatment: Drug: propofol, bupivacaine; Drug: sevoflurane, rocuronium

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nonintubated group; Patients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine.	Drug: propofol, bupivacaine; Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.; Other Names: Fresofol, Marcaine
ACTIVE_COMPARATOR: Intubated group; Patients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium.	Drug: sevoflurane, rocuronium; Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.; Other Names: Ultane, Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.		1 month
Changes of inflammatory cytokines before and after surgery.	Inflammatory responses	3 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jin-Shing Chen, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ANTICIPATED): October 1, 2016
• Study Completion (ANTICIPATED): October 1, 2016

Study Registration Dates

• First Submitted: March 8, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (ESTIMATE): March 19, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Recovery; Thoracoscopy; Tracheal intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Local; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Sevoflurane; Bupivacaine; Rocuronium
• Other Study ID Numbers: 201410045RINB