Primary Spontaneous PneumothoraxNCT02109510
Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy
A study testing nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration, intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas and single port thoracoscopic bullectomy in people with Primary Spontaneous Pneumothorax, run by Korea University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Primary Spontaneous Pneumothorax
- What is being tested?
- nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration, intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas and single port thoracoscopic bullectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- primary spontaneous pneumothorax
- Age between 13 and 30
- ASA score 1,2
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Ansan Hospital, Korea University College of Medicine
Ansan, Outside U.S and Canada, 425-707
About this study
Official title: 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
- postoperative Visual scale of pain
- postoperative sore throat/voice change
- postoperative nausea/vomiting
- intraoperative Arterial blood gas analysis
- cost for anesthesia
- morbidity
Read the 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).
- Conditions
- Primary Spontaneous Pneumothorax
- Being tested
- nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration, intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas, single port thoracoscopic bullectomy
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltrationDrug
intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gasDrug
single port thoracoscopic bullectomyProcedure or surgery
Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas; Procedure: single port thoracoscopic bullectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the postoperative discomforts after intervention of each group
post operative pain/sore throat/voice change
Measured: participants will be checked at 1 hour and 24 hours later after finishing operations
Secondary outcomes (1)
intraoperative Arterial Blood Gas Analysis
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwook, Hwang, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109510
- Sponsor's protocol ID
- NISIVATS01
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Single Port Thoracoscopic Bullectomy Under Nonintubated Local and Sedation Anesthesia Versus Intubated General Anesthesia for Primary Spontaneous Pneumothorax.
- ClinicalTrials.gov ID
- NCT02109510
- Acronym / sponsor ID
- NISIVATS01
- Conditions
- Primary Spontaneous Pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- postoperative Visual scale of pain
- postoperative sore throat/voice change
- postoperative nausea/vomiting
- intraoperative Arterial blood gas analysis
- cost for anesthesia
- morbidity
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonintubated sedation anesthesia | Experimental | Drug: nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration, Procedure: single port thoracoscopic bullectomynonintubated 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 general anesthesia | Active comparator | Drug: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas, Procedure: single port thoracoscopic bullectomyintubated 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 |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- primary spontaneous pneumothorax
- Age between 13 and 30
- ASA score 1,2
- written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 bullectomyThoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space. | Procedure or surgery | Intubated general anesthesia, Nonintubated sedation anesthesia |
Primary outcome
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
1 secondary outcome
intraoperative Arterial Blood Gas Analysis
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration, intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas and single port thoracoscopic bullectomy in people with Primary Spontaneous Pneumothorax, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.