NCT03469323

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

March 13, 2018

Last Update Submit

March 18, 2018

Conditions

Keywords

Nonintubated video-assisted thoracic surgery (VATS)

Outcome Measures

Primary Outcomes (1)

  • Quality of lung collapse

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

    20 minutes

Secondary Outcomes (1)

  • Arterial blood gas analysis

    20 minutes

Study Arms (2)

Nonintubated VATS succinylcholine

EXPERIMENTAL

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

Drug: Succinylcholine

Nonintubated VATS placebo

PLACEBO COMPARATOR

Nonintubated VATS not using succinylcholine in the beginning of open pneumothorax

Drug: Placebo

Interventions

Giving mini-dose succinylcholine to facilitate lung collapse during nonintubated VATS.

Also known as: Suxamethonium
Nonintubated VATS succinylcholine

Giving placebo (normal saline) to facilitate lung collapse during nonintubated VATS.

Also known as: Normal saline
Nonintubated VATS placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

SuccinylcholineSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOnium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ming-Hui Hung, MD, MSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Hui Hung, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 19, 2018

Study Start

March 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations