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

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ClinicalTrials.gov Identifier: NCT02109510
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Jinwook, Hwang, Korea University

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

Condition or disease Intervention/treatment Phase
Primary Spontaneous Pneumothorax Drug: 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 Procedure: single port thoracoscopic bullectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Single Port Thoracoscopic Bullectomy Under Nonintubated Local and Sedation Anesthesia Versus Intubated General Anesthesia for Primary Spontaneous Pneumothorax.
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013


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
Drug: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. intraoperative Arterial Blood Gas Analysis [ Time Frame: during operation ]


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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109510


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

Responsible Party: Jinwook, Hwang, Clinical Assistant Professor, Korea University
ClinicalTrials.gov Identifier: NCT02109510     History of Changes
Other Study ID Numbers: NISIVATS01
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Anesthetics
Lidocaine
Propofol
Ketamine
Sevoflurane
Dexmedetomidine
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents