Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery

Atelectasis Clinical Trial

Official title:

Can Mini-dose Succinylcholine Accelerate Lung Collapse and Intrathoracic Nerve Blocks During Nonintubated Thoracoscopic Surgery? A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469323
• Other study ID #: 201711080MINB
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 18, 2018
• Start date: March 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2018
• Source: National Taiwan University Hospital
• Contact: Ming-Hui Hung, MD, MSc
• Phone: +886-2-23123456
• Email: hung.minghui[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atelectasis
• Complication of Ventilation Therapy
• Lung Neoplasms
• Pulmonary Atelectasis
• Tumor of Lung Parenchyma

Intervention

Drug:
• Succinylcholine
Giving mini-dose succinylcholine to facilitate lung collapse during nonintubated VATS.
• Placebo
Giving placebo (normal saline) to facilitate lung collapse during nonintubated VATS.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of lung collapse	Quality of lung collapse will be quantified by the surgeon as score 1-3.	20 minutes
Secondary	Arterial blood gas analysis	Arterial partial pressure of carbon dioxide (PaCO2) and oxgen (PaO2) levels after succinylcholine and placebo during one-lung ventilation	20 minutes