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

Lung Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663242
• Other study ID #: KMUHIRB-F(I)-20210218.
• Status: Recruiting
• Phase: Phase 4
• Start date: December 27, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Hung-Te Hsu, MD
• Phone: 07-3121101
• Email: hdhsu1228[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Disease Progression
• Lung Cancer
• Progression, Disease

Intervention

Drug:
• Propofol
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.
• Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time of operation and anesthesia	record the time the opeartion and anesthesia	time of the total procedure
Other	blood loss	record the blood loss (ml)	during the operation of VATS
Other	volume of blood transfusion	volume of blood transfusion (ml)	during the operation of VATS
Primary	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
Primary	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	Postoperative complications	Clavien-Dindo classification, and other postoperative complications	The period from the day of surgery to postoperative 30 days
Secondary	Karnofsky performance status score	to access patients' functional impairment	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
Secondary	Length of hospital stays	the length of stays in general ward and ICU	from the day of surgery to dischage, assessed up to 30 days