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

NCT05926336 | Recruiting Phase 4

• 1 other identifier: KMUHIRB-F(I)-20230075
• Study Type: interventional
• Target: 1,316
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Eligible participants were assessed prior to anesthesia. After the patient is admitted to the hospital, the subject's consent form is explained, and the consent form must be signed before the operation.
2. 2.This is a two-arm, parallel-group randomized clinical trial.In the preoperative waiting area, the patients are randomly assigned and divided into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. 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. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). 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 (KPS) score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), ASA physical status scores, tumor marker ,tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, 3-year and 5-year overall survival and Karnofsky performance status score were recorded.

Conditions

Lung Cancer; Brain Tumor; Liver Cancer; Ovarian Cancer

Keywords

Propofol; Sevoflurane; Survival

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

  postoperation 6 months, postoperation 12 months,postoperation 36 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

  from start to end of the procedure

• blood loss

  from start to end of the procedure

• volume of blood transfusion

  from start to end of the procedure

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
• Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia

You may not qualify if:

• Severe 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 brain, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.

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; Brain Neoplasms; Liver Neoplasms; Ovarian Neoplasms

Interventions

Propofol; Sevoflurane; Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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

Study Officials

• Zhi-Fu Wu

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Fu Wu, MD

CONTACT

07-3121101; aneswu@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 3, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-05

Locations

TW (1)