Clinical trial NCT02109510: Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
Official title: Comparative Study of Single Port Thoracoscopic Bullectomy Under Nonintubated Local and Sedation Anesthesia Versus Intubated General Anesthesia for Primary Spontaneous Pneumothorax.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Spontaneous Pneumothorax
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. primary spontaneous pneumothorax
2. Age between 13 and 30
3. ASA score 1,2
4. written informed consent

Exclusion Criteria:

1. A history of previous bullectomy or ipsilateral thoracic operation
2. Pregnant or lactation female
3. A cognition or mental dysfunction
4. Consumption of oral sedatives
5. A present sore throat or hoarseness
6. ASA score greater than 3

Primary outcomes:
measure: comparing the postoperative discomforts after intervention of each group
timeFrame: participants will be checked at 1 hour and 24 hours later after finishing operations
Secondary outcomes:
measure: intraoperative Arterial Blood Gas Analysis
timeFrame: during operation
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital, Korea University College of Medicine
state: Outside U.S and Canada
Study officials:
References: