Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05926336

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

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. 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Zhi-Fu Wu

CONTACT

About this study

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

Exclusion criteria

  • 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.

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: postoperation 6 months, postoperation 12 months,postoperation 36 months.

    Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival.

  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: from start to end of the procedure

    record the time the opeartion and anesthesia

  2. blood loss

    Time frame: from start to end of the procedure

    record the blood loss (ml)

  3. volume of blood transfusion

    Time frame: from start to end of the procedure

    volume of blood transfusion (ml)

Study contacts

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

Zhi-Fu Wu, 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 Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Sep 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.