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

April 7, 2014 updated by: Jinwook, Hwang, Korea University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Outside U.S and Canada
      • Ansan, Outside U.S and Canada, Korea, Republic of, 425-707
        • Korea University Ansan Hospital, Korea University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Procedure: single port thoracoscopic bullectomy
Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
Drug: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing the postoperative discomforts after intervention of each group
Time Frame: participants will be checked at 1 hour and 24 hours later after finishing operations
post operative pain/sore throat/voice change
participants will be checked at 1 hour and 24 hours later after finishing operations

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative Arterial Blood Gas Analysis
Time Frame: during operation
during operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NISIVATS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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