Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
- Conditions
- Primary Spontaneous Pneumothorax
- Interventions
- Registration Number
- NCT02109510
- Lead Sponsor
- Korea University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- primary spontaneous pneumothorax
- Age between 13 and 30
- ASA score 1,2
- written informed consent
- A history of previous bullectomy or ipsilateral thoracic operation
- Pregnant or lactation female
- A cognition or mental dysfunction
- Consumption of oral sedatives
- A present sore throat or hoarseness
- ASA score greater than 3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nonintubated sedation anesthesia nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration nonintubated single port thoracoscopic bullectomy using local anesthesia under sedation Drug: Dexmedetomidine IV loading dose of 1ug/kg for 10 minutes and maintain dosage of 0.3-1 ug/kg/hr, ketamine IV 2-4 mg/kg/hr and intercostal nerve block with 2% lidocaine 2cc Device: facial O2 Mask Nonintubated sedation anesthesia single port thoracoscopic bullectomy nonintubated single port thoracoscopic bullectomy using local anesthesia under sedation Drug: Dexmedetomidine IV loading dose of 1ug/kg for 10 minutes and maintain dosage of 0.3-1 ug/kg/hr, ketamine IV 2-4 mg/kg/hr and intercostal nerve block with 2% lidocaine 2cc Device: facial O2 Mask Intubated general anesthesia intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas intubated single port thoracoscopic bullectomy under general anesthesia Drug: propofol 2mg/kg IV , rocuronium 0.6mg/kg IV,1.2-2.4% sevoflurane, N20 50% 02 at fresh gas flow of 4L/min Device: double lumen endotracheal tube intubation Intubated general anesthesia single port thoracoscopic bullectomy intubated single port thoracoscopic bullectomy under general anesthesia Drug: propofol 2mg/kg IV , rocuronium 0.6mg/kg IV,1.2-2.4% sevoflurane, N20 50% 02 at fresh gas flow of 4L/min Device: double lumen endotracheal tube intubation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method intraoperative Arterial Blood Gas Analysis during operation
Trial Locations
- Locations (1)
Korea University Ansan Hospital, Korea University College of Medicine
🇰🇷Ansan, Outside U.S and Canada, Korea, Republic of
Korea University Ansan Hospital, Korea University College of Medicine🇰🇷Ansan, Outside U.S and Canada, Korea, Republic of