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

NCT02109510 | Completed DMC

• 1 other identifier: NISIVATS01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.postoperative Visual scale of pain
2. 2.postoperative sore throat/voice change
3. 3.postoperative nausea/vomiting
4. 4.intraoperative Arterial blood gas analysis
5. 5.cost for anesthesia
6. 6.morbidity

Conditions

Primary Spontaneous Pneumothorax

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• intraoperative Arterial Blood Gas Analysis

  during operation

Study Arms (2)

Nonintubated sedation anesthesia

EXPERIMENTAL

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

Intubated general anesthesia

ACTIVE COMPARATOR

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

Interventions

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

Nonintubated sedation anesthesia

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

Intubated general anesthesia

single port thoracoscopic bullectomy PROCEDURE

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

Intubated general anesthesia; Nonintubated sedation anesthesia

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• primary spontaneous pneumothorax
• Age between 13 and 30
• ASA score 1,2
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead

Study Sites (1)

Korea University Ansan Hospital, Korea University College of Medicine

Ansan, Outside U.S and Canada, 425-707, South Korea

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 10, 2014
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

KR (1)