Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)

Ovarian Cancer Clinical Trial

— anesthetics  

Official title:

Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606692
• Other study ID #: KMUHIRB-F(II)-20220157
• Status: Recruiting
• Phase: Phase 4
• Start date: November 23, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: October 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Zhi-Fu Wu, MD
• Phone: 07-3121101
• Email: aneswu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ⅶ. Study procedures (summary)

1. Written informed consent must be obtained before any study specific procedures are undertaken.

Qualified participants were identified at the pre-anesthesia evaluation clinic or ward. The informed consents are obtained from the patient in the ward at night before the operation.

2. The process of the experiment (brief describe) 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Twenty to eighty-year-old.

2. ASA class I-III.

3. Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia.

Exclusion Criteria:

1. Severe mental disorder

2. Poor liver function

3. Pregnant or lactating women

4. Morbid obesity

5. Have a history of allergy to any drug used in this study

6. Non-primary ovarian cancer surgery

7. Undergoing ovarian cancer pathological section surgery

8. Patients with incomplete medical records

9. Combined with other surgeries, emergency surgeries

10. Concomitant patients with other non-ovarian cancer therapy

11. Patients receiving palliative treatment after ovarian cancer surgery

12. During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs

13. Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics)

14. Those diagnosed with benign tumors before and after surgery

15. Patients with metastases to the ovary

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	progression-free survival	5 years
Secondary	6-month overall survival	6-month overall survival	6 months
Secondary	1-year overall survival	1-year overall survival	1 year
Secondary	3-year overall survival	3-year overall survival	3 years
Secondary	5-year overall survival	5-year overall survival	5 years
Secondary	Karnofsky performance score	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.	5 years
Secondary	postoperative complications	postoperative complications within 30 days (according Clavien-Dindo classification)	30 days