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

Primary Spontaneous Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109510
• Other study ID #: NISIVATS01
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 7, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax
• Primary Spontaneous Pneumothorax

Intervention

Drug:
• 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

Procedure:
• single port thoracoscopic bullectomy
Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital, Korea University College of Medicine	Ansan	Outside U.S and Canada

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing the postoperative discomforts after intervention of each group	post operative pain/sore throat/voice change	participants will be checked at 1 hour and 24 hours later after finishing operations	No
Secondary	intraoperative Arterial Blood Gas Analysis		during operation	Yes