Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

Not Applicable

Suspended

• Conditions: Intubation

• Registration Number: NCT04253795
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).

Detailed Description

Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-02-01
• Study First Posted: 2020-02-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30
• Study Start: 2020-09
• Primary Completion: 2020-12
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing elective minor VATS procedures will be enrolled the study

Exclusion Criteria

• patients <18 years old,
• body mass index (BMI)>30 kg/m2,
• American Society Association (ASA) Class>3,
• heart failure (New York Heart Association class > II),
• a history of arrhythmia or treatment with antiarrhythmic drugs,
• bradycardia (heart rate (HR) <45 beats min1)
• atrioventricular block,
• hepatic or renal dysfunction,
• coagulopathy,
• asthma
• sleep apnea syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
difference in PaO2/FiO2 ratio at the end of the surgery	1 hour	PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery

Secondary Outcome Measures

Name	Time	Method
Post anesthetic care unit (PACU) time	30 minutes	PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.
Surgeon satisfaction	10 minutes	Surgeon will be asked to rate his satisfaction with the surgical conditions using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").
Patient satisfaction	10 minutes	Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").
Anesthesia time	20 minutes	Anesthesia time will be defined in minute as the time from starting electronically monitored in the operating room until the time the double lumen tube or laryngeal mask was correctly placed
Operating room time	1 hour	Operating room time will be defined in minute as the time from arrival to operating room until the patient will be transferred to the post anesthetic care unit.

Trial Locations

Locations (1)

Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation; 🇹🇷 Antalya, Turkey