NCT02109510

Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy

Comparative Study of Single Port Thoracoscopic Bullectomy Under Nonintubated Local and Sedation Anesthesia Versus Intubated General Anesthesia for Primary Spontaneous Pneumothorax.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 13 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

Investigators compared the patients' subjective postoperative symptoms and complications between the double lumen endotracheal intubated patients under general anesthesia and non-intubated patients under sedation and local anesthesia including 1. postoperative Visual scale of pain 2. postoperative sore throat/voice change 3. postoperative nausea/vomiting 4. intraoperative Arterial blood gas analysis 5. cost for anesthesia 6. morbidity

Detailed description

Thoracoscopic bullectomy for primary spontaneous pneumothorax is relatively simple and short procedure compared to other thoracic surgery. However, in the anesthetic preparation, complicated technique and procedures are needed including a double lumen endotracheal intubation, auscultation, and flexible bronchoscopic confirmation of the tube location, even during lateral decubitus position. The double lumen endotracheal tube has a bigger outer diameter. And postoperative sore throat and voice change can develop after the intubation procedure. Recently, single lumen intubation using carbon dioxide gas instillation under general anesthesia during thoracoscopic surgery is reported. However, if safety and efficacy are warranted, thoracoscopic surgery using nonintubated and self-ventilated anesthesia will be a best solution for above mentioned postoperative discomforts. Investigators designed the comparative study of nonintubated local anesthesia under sedation and intubated general anesthesia in thoracoscopic bullectomy through the single port. Investigators will investigate postoperative pain, sore throat, voice change, nausea, vomiting, and intraoperative arterial blood gas analysis. This study will be performed at Korea University Ansan Hospital. A total of 40 patients will be enrolled (20 patients in each arm).

Conditions

• Primary Spontaneous Pneumothorax

Interventions

Type	Name	Description
DRUG	nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration
DRUG	intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
PROCEDURE	single port thoracoscopic bullectomy	Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2014-04-10
• Last updated: 2014-04-10

Locations

1 site across 1 country: South Korea