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

Korea University

Status: Completed

Conditions: Primary Spontaneous Pneumothorax

Treatments: Drug: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas; Drug: nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration; Procedure: single port thoracoscopic bullectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02109510

NISIVATS01

Details and patient eligibility

About

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

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 13 to 30 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Nonintubated sedation anesthesia

Experimental group

Description:

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

Treatment:

Drug: nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration

Procedure: single port thoracoscopic bullectomy

Intubated general anesthesia

Active Comparator group

Description:

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

Treatment:

Procedure: single port thoracoscopic bullectomy

Drug: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas