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Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery

Primary Purpose

Tumor of Lung Parenchyma, Complication of Ventilation Therapy, Atelectasis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Succinylcholine
Placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tumor of Lung Parenchyma focused on measuring Nonintubated video-assisted thoracic surgery (VATS)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults patients with lung tumors and elective for unilateral thoracoscopic surgery.

Exclusion Criteria:

  • Over weighted, body mass index > 26 kg/m2.
  • Previous thoracic surgery on the attempted operative side.
  • Hypoventilation syndrome requiring positive pressure ventilatory support or oxygen at home.
  • Relevant systemic disease, including heart failure, liver failure, renal failure with an American Society of Anesthesiologists (ASA) class above 3.
  • Difficult airway management.
  • Pregnancy.
  • Contraindications for succinylcholine, including family history of suspicious malignant hyperthermia, hyperkalemia, or other neuromuscular diseases.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nonintubated VATS succinylcholine

Nonintubated VATS placebo

Arm Description

Nonintubated VATS using mini-dose succinylcholine in the beginning of open pneumothorax

Nonintubated VATS not using succinylcholine in the beginning of open pneumothorax

Outcomes

Primary Outcome Measures

Quality of lung collapse
Quality of lung collapse will be quantified by the surgeon as score 1-3.

Secondary Outcome Measures

Arterial blood gas analysis
Arterial partial pressure of carbon dioxide (PaCO2) and oxgen (PaO2) levels after succinylcholine and placebo during one-lung ventilation

Full Information

First Posted
March 13, 2018
Last Updated
March 18, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03469323
Brief Title
Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery
Official Title
Can Mini-dose Succinylcholine Accelerate Lung Collapse and Intrathoracic Nerve Blocks During Nonintubated Thoracoscopic Surgery? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A safe and effective surgical environment is important for nonintubated thoracoscopic surgery. The investigators hypothesize that mini-dose succinylcholine can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery.
Detailed Description
Background: Nonintubated thoracoscopic surgery is the frontier of modern minimal invasive thoracic surgery. A safe and effective surgical environment is established via an iatrogenic open pneumothorax producing the operated lung fully collapsed. However, the initial respiratory response to open pneumothorax is both tachypnea and carbon dioxide rebreathing, which would jeopardize the quality of collapse of the operated lung and delay the performance of intrathoracic vagal block. Intravenous opioid is effective to attenuate ventilatory responses but herein with risk of persistent respiratory depression. Methods: The investigators hypothesize that mini-dose succinylcholine 0.15 mg/kg can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery. In a prospective, randomized, double-blind study design, 30 patients will be allocated to receive either succinylcholine (n=15) or placebo (n=15) in the beginning of open pneumothorax. The effectiveness of succinylcholine will be measured by the surgeon's evaluation of the quality of lung collapse, while the safety will be evaluated by determination of arterial blood gases within 20 minutes of one-lung spontaneous breathing. Expected results: Mini-dose succinylcholine can facilitate early lung collapse without jeopardizing the ventilatory function during nonintubated thoracoscopic surgery with one-lung spontaneous breathing, which may make nonintubated thoracoscopic surgery easier and safer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor of Lung Parenchyma, Complication of Ventilation Therapy, Atelectasis
Keywords
Nonintubated video-assisted thoracic surgery (VATS)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nonintubated VATS succinylcholine
Arm Type
Experimental
Arm Description
Nonintubated VATS using mini-dose succinylcholine in the beginning of open pneumothorax
Arm Title
Nonintubated VATS placebo
Arm Type
Placebo Comparator
Arm Description
Nonintubated VATS not using succinylcholine in the beginning of open pneumothorax
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Other Intervention Name(s)
Suxamethonium
Intervention Description
Giving mini-dose succinylcholine to facilitate lung collapse during nonintubated VATS.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Giving placebo (normal saline) to facilitate lung collapse during nonintubated VATS.
Primary Outcome Measure Information:
Title
Quality of lung collapse
Description
Quality of lung collapse will be quantified by the surgeon as score 1-3.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Arterial blood gas analysis
Description
Arterial partial pressure of carbon dioxide (PaCO2) and oxgen (PaO2) levels after succinylcholine and placebo during one-lung ventilation
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults patients with lung tumors and elective for unilateral thoracoscopic surgery. Exclusion Criteria: Over weighted, body mass index > 26 kg/m2. Previous thoracic surgery on the attempted operative side. Hypoventilation syndrome requiring positive pressure ventilatory support or oxygen at home. Relevant systemic disease, including heart failure, liver failure, renal failure with an American Society of Anesthesiologists (ASA) class above 3. Difficult airway management. Pregnancy. Contraindications for succinylcholine, including family history of suspicious malignant hyperthermia, hyperkalemia, or other neuromuscular diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Hui Hung, MD, MSc
Phone
+886-2-23123456
Ext
62158
Email
hung.minghui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Hui Hung, MD, MSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Hui Hung, MD, MSc

12. IPD Sharing Statement

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Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery

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