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

Ketamine

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

Intervention / Treatment

  • nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration (DRUG)
    N/A
  • intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas (DRUG)
    N/A
  • single port thoracoscopic bullectomy (PROCEDURE)
    Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.

Condition or Disease

  • Primary Spontaneous Pneumothorax

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 13 Years to 30 Years
    Enrollment: 40 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Nov 01, 2012
    Primary Completion: Sep 01, 2013 ACTUAL
    Completion Date: Nov 01, 2013 ACTUAL
    Study First Posted: Apr 10, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 07, 2014

    Sponsors / Collaborators

    Lead Sponsor: Korea University
    Responsible Party: N/A

    Location

    South Korea

    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).

    Participant Groups

    • 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

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 13
    Maximum Age: 30
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • post operative pain/sore throat/voice change

    Secondary Outcomes
    • intraoperative Arterial Blood Gas Analysis during operation

    More Details

    NCT Number: NCT02109510
    Other IDs: NISIVATS01
    Study URL: https://clinicaltrials.gov/study/NCT02109510
    Last updated: Sep 29, 2023