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NCT Number: NCT05663242

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Location contact

Hung-Te Hsu

CONTACT

About this study

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: total intravenous anesthesia

Sevoflurane

Drug

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

Other names: inhalation anesthesia

Primary outcomes

  1. Overall survival

    Time frame: 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

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

  2. The presence of disease progression

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

    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

Secondary outcomes

  1. Postoperative complications

    Time frame: The period from the day of surgery to postoperative 30 days

    Clavien-Dindo classification, and other postoperative complications

  2. Karnofsky performance status score

    Time frame: 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

    to access patients' functional impairment

  3. Length of hospital stays

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

    the length of stays in general ward and ICU

Other outcomes

  1. time of operation and anesthesia

    Time frame: time of the total procedure

    record the time the opeartion and anesthesia

  2. blood loss

    Time frame: during the operation of VATS

    record the blood loss (ml)

  3. volume of blood transfusion

    Time frame: during the operation of VATS

    volume of blood transfusion (ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Hung-Te Hsu, MD

CONTACT

[email protected]

07-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Lung Tumors and the Investigation of Its Mechanism of Action.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2022
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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