The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action

NCT05663242 | Recruiting Phase 4

• 1 other identifier: KMUHIRB-F(I)-20210218.
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.

Conditions

Lung Cancer; Progression, Disease; Anesthesia

Keywords

Propofol; Sevoflurane; Lung Cancer; VATS

Outcome Measures

Primary Outcomes (2)

• Overall survival

  6-month overall survival, 1-year overall survival, and 3-year overall survival

  From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

• The presence of disease progression

  From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months

  From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months

Secondary Outcomes (3)

• Postoperative complications

  The period from the day of surgery to postoperative 30 days

• Karnofsky performance status score

  Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months

• Length of hospital stays

  from the day of surgery to dischage, assessed up to 30 days

Other Outcomes (3)

• time of operation and anesthesia

  time of the total procedure

• blood loss

  during the operation of VATS

• volume of blood transfusion

  during the operation of VATS

Study Arms (2)

Sevoflurane

EXPERIMENTAL

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).

Drug: Sevoflurane

Propofol

EXPERIMENTAL

The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

Drug: Propofol

Interventions

Propofol DRUG

The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

Also known as: total intravenous anesthesia

Propofol

Sevoflurane DRUG

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Also known as: inhalation anesthesia

Sevoflurane

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eighteen to eighty-year-old
• ASA class I-III patients
• Received elective thoracic surgery for primary lung tumors under general anesthesia

You may not qualify if:

• mental disorder
• poor liver function
• pregnant or lactating women
• morbidly obese
• allergy to any of the drugs used in this study
• recurrent tumor or repeat surgery
• biopsy cases
• incomplete outcome-data
• palliative treatment after surgery
• simultaneous treatment of other malignancies
• emergency surgery
• presence of other malignant tumors
• combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
• diagnosed as benign lung tumor, or other metastatic lung tumor

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease Progression

Interventions

Propofol; Sevoflurane; Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Hung-Te Hsu, MD

CONTACT

07-3121101; hdhsu1228@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: December 27, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

TW (1)