Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Atelectasis; Complication of Ventilation Therapy; Tumor of Lung Parenchyma
• Intervention / Treatment: Drug: Succinylcholine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming-Hui Hung, MD, MSc; Phone Number: 62158 +886-2-23123456; Email: hung.minghui@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ming-Hui Hung, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonintubated VATS succinylcholine; Nonintubated VATS using mini-dose succinylcholine in the beginning of open pneumothorax	Drug: Succinylcholine; Giving mini-dose succinylcholine to facilitate lung collapse during nonintubated VATS.; Other Names: Suxamethonium
Placebo Comparator: Nonintubated VATS placebo; Nonintubated VATS not using succinylcholine in the beginning of open pneumothorax	Drug: Placebo; Giving placebo (normal saline) to facilitate lung collapse during nonintubated VATS.; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of lung collapse	Quality of lung collapse will be quantified by the surgeon as score 1-3.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ming-Hui Hung, MD, MSc, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Nonintubated video-assisted thoracic surgery (VATS)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Succinylcholine
• Other Study ID Numbers: 201711080MINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No