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NCT Number: NCT02109510

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

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

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Key information

Conditions

Primary Spontaneous Pneumothorax Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Ansan Hospital, Korea University College of Medicine

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

single port thoracoscopic bullectomy

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. intraoperative Arterial Blood Gas Analysis

    Time frame: during operation

Sponsors and collaborators

Lead sponsor

Korea University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2014
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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