Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
Primary Purpose
Primary Spontaneous Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration
intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
single port thoracoscopic bullectomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Spontaneous Pneumothorax
Eligibility Criteria
Inclusion Criteria:
- primary spontaneous pneumothorax
- Age between 13 and 30
- ASA score 1,2
- written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Korea University Ansan Hospital, Korea University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nonintubated sedation anesthesia
Intubated general anesthesia
Arm 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
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
Outcomes
Primary Outcome Measures
comparing the postoperative discomforts after intervention of each group
post operative pain/sore throat/voice change
Secondary Outcome Measures
intraoperative Arterial Blood Gas Analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02109510
Brief Title
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
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University
4. Oversight
Data Monitoring Committee
Yes
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Spontaneous Pneumothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nonintubated sedation anesthesia
Arm Type
Experimental
Arm 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
Arm Title
Intubated general anesthesia
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration
Intervention Type
Drug
Intervention Name(s)
intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
Intervention Type
Procedure
Intervention Name(s)
single port thoracoscopic bullectomy
Intervention Description
Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
Primary Outcome Measure Information:
Title
comparing the postoperative discomforts after intervention of each group
Description
post operative pain/sore throat/voice change
Time Frame
participants will be checked at 1 hour and 24 hours later after finishing operations
Secondary Outcome Measure Information:
Title
intraoperative Arterial Blood Gas Analysis
Time Frame
during operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary spontaneous pneumothorax
Age between 13 and 30
ASA score 1,2
written informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Korea University Ansan Hospital, Korea University College of Medicine
City
Ansan
State/Province
Outside U.S and Canada
ZIP/Postal Code
425-707
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
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