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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02109510

Enrollment

Registered

2014-04-10

Start date

2012-11-30

Completion date

2013-11-30

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Spontaneous Pneumothorax

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).

Interventions

DRUGnonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration

DRUGintubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

PROCEDUREsingle port thoracoscopic bullectomy

Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 30 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
comparing the postoperative discomforts after intervention of each group	participants will be checked at 1 hour and 24 hours later after finishing operations	post operative pain/sore throat/voice change

Secondary

Measure	Time frame
intraoperative Arterial Blood Gas Analysis	during operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026