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

NCT ID: NCT02109510

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-11-30

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).

Conditions

Primary Spontaneous Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

single port thoracoscopic bullectomy

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

single port thoracoscopic bullectomy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

single port thoracoscopic bullectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University

OTHER

Sponsor Role: lead

Responsible Party

Jinwook, Hwang

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Ansan Hospital, Korea University College of Medicine

Ansan, Outside U.S and Canada, South Korea

Countries

South Korea

Other Identifiers

NISIVATS01

Identifier Type: -

Identifier Source: org_study_id