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

Sponsor

Korea University (Other)

Overall Status

Completed

CT.gov ID

NCT02109510

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

postoperative Visual scale of pain
postoperative sore throat/voice change
postoperative nausea/vomiting
intraoperative Arterial blood gas analysis
cost for anesthesia
morbidity

Condition or Disease	Intervention/Treatment	Phase
Primary Spontaneous Pneumothorax	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	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nonintubated sedation anesthesia 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	Drug: nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration Procedure: single port thoracoscopic bullectomy Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
Active Comparator: Intubated general anesthesia 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	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.

Arm

Intervention/Treatment

Experimental: Nonintubated sedation anesthesia

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

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

Procedure: single port thoracoscopic bullectomy

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

Active Comparator: Intubated general anesthesia

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

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.

Outcome Measures

Primary Outcome Measures

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