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

NCT02393664 | Unknown Phase 2

• 1 other identifier: 201410045RINB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

Thoracoscopy; Recovery; Tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Composite outcomes, including perioperative adverse effects, mortality, ICU stay, hospital stay, ventilator use, etc.

  1 month

• Changes of inflammatory cytokines before and after surgery.

  3 days

Study Arms (2)

Nonintubated group

EXPERIMENTAL

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

Drug: propofol, bupivacaine

Intubated group

ACTIVE COMPARATOR

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

Drug: sevoflurane, rocuronium

Interventions

propofol, bupivacaine DRUG

Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.

Also known as: Fresofol, Marcaine

Nonintubated group

sevoflurane, rocuronium DRUG

Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.

Also known as: Ultane, Esmeron

Intubated group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Propofol; Bupivacaine; Sevoflurane; Rocuronium

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jin-Shing Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Hui Hung, MD, MSc

CONTACT

886-2-23123456; hung.minghui@gmail.com

Ya-Jung Cheng, MD, PhD

CONTACT

886-2-23123456; chengyj@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

TW (1)