Impact of Anesthesia Maintenance Methods on 5-year Survival After Surgery

NCT05343260 | Completed DMC

• 2 other identifiers: 2015[869]-3ChiCTR-IPR-15006209
• Study Type: interventional
• Target: 1,228
• Locations: 1 country
• Sites: 15

Brief Summary

Surgery is one of the major treatment methods for patients with solid organ cancer. And, alone with the ageing process, more and more elderly patients undergo surgery for cancer. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From the point of view of immune function after surgery and invasiveness of malignant tumor cells, propofol intravenous anesthesia may be superior to inhalational anesthesia. However, the clinical significance of these effects remains unclear. Retrospective studies indicated that use of propofol intravenous anesthesia was associated higher long-term survival rate. Prospective studies exploring the effect of anesthetic choice on long-term survival in cancer surgery patients are urgently needed.

Conditions

Aged; Neoplasms; Surgical Procedure, Operative; Anesthesia, Inhalation; Anesthesia, Intravenous; Survival

Keywords

Sevoflurane; Propofol; Aged; Neoplasm; Surgical Procedure, Operative; 5-year survival

Outcome Measures

Primary Outcomes (1)

• Over survival after surgery.

  Time from surgery to the date of all-cause death.

  Up to 5 years after surgery

Secondary Outcomes (2)

• Recurrence-free survival after surgery

  Up to 5 years after surgery

• Event-free survival after surgery

  Up to 5 years after surgery

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

Anesthesia will be induced intravenously with midazolam (0.015-0.03 mg/kg), sufentanil, propofol, and rocuronium. Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, sevoflurane inhalational concentration will be decreased and fentanyl/sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery.

Drug: Sevoflurane

Propofol group

EXPERIMENTAL

Anesthesia will be induced intravenously with midazolam (0.015-0.03 mg/kg), sufentanil, propofol, and rocuronium. Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, propofol infusion rate will be decreased and fentanyl/sufentanil will be administered when necessary. Propofol infusion will be stopped at the end of surgery.

Drug: Propofol

Interventions

Sevoflurane DRUG

Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60. Sevoflurane inhalational concentration will be decreased towards the end of surgery. Sevoflurane inhalation will be stopped at the end of surgery.

Also known as: Sevoflurane for inhalation

Sevoflurane group

Propofol DRUG

Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Propofol infusion rate will be decreased towards the end of surgery. Propofol infusion will be stopped at the end of surgery.

Also known as: Propofol for injection

Propofol group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants will be included if they meet all the following criteria:
• Age ≥ 65 years and \< 90 years;
• Primary malignant tumor;
• Do not receive radiation therapy or chemotherapy before surgery;
• Scheduled to undergo surgery for the treatment of tumors, with an expected duration of 2 hours or more, under general anesthesia;
• Agree to participate, and give signed written informed consent.

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
• Inability to communicate in the preoperative period (coma, profound dementia, language barrier, or end-stage disease);
• Critical illness (preoperative American Society of Anesthesiologists physical status classification ≥ IV);
• Severe hepatic dysfunction (Child-Pugh class C), or severe renal dysfunction (undergoing dialysis before surgery);
• Neurosurgery.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (15)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Location

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

Hebei Medical University Forth Hospital

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Zhongda Hospital

Nanjing, Jiangsu, China

Location

Ningxia People's Hospital

Yinchuan, Ningxia, China

Location

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Location

Tang-Du Hospital

Xi'an, Shaanxi, China

Location

Shaanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

Location

Tianjin Nankai Hospital

Tianjin, China

Location

Related Publications (18)

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• Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.

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• Wang P, Chen J, Mu LH, Du QH, Niu XH, Zhang MY. Propofol inhibits invasion and enhances paclitaxel- induced apoptosis in ovarian cancer cells through the suppression of the transcription factor slug. Eur Rev Med Pharmacol Sci. 2013 Jul;17(13):1722-9.

  PMID: 23852894 BACKGROUND

• Ecimovic P, Murray D, Doran P, Buggy DJ. Propofol and bupivacaine in breast cancer cell function in vitro - role of the NET1 gene. Anticancer Res. 2014 Mar;34(3):1321-31.

  PMID: 24596379 BACKGROUND

• Huang H, Benzonana LL, Zhao H, Watts HR, Perry NJ, Bevan C, Brown R, Ma D. Prostate cancer cell malignancy via modulation of HIF-1alpha pathway with isoflurane and propofol alone and in combination. Br J Cancer. 2014 Sep 23;111(7):1338-49. doi: 10.1038/bjc.2014.426. Epub 2014 Jul 29.

  PMID: 25072260 BACKGROUND

• Benzonana LL, Perry NJ, Watts HR, Yang B, Perry IA, Coombes C, Takata M, Ma D. Isoflurane, a commonly used volatile anesthetic, enhances renal cancer growth and malignant potential via the hypoxia-inducible factor cellular signaling pathway in vitro. Anesthesiology. 2013 Sep;119(3):593-605. doi: 10.1097/ALN.0b013e31829e47fd.

  PMID: 23774231 BACKGROUND

• Liang H, Gu M, Yang C, Wang H, Wen X, Zhou Q. Sevoflurane inhibits invasion and migration of lung cancer cells by inactivating the p38 MAPK signaling pathway. J Anesth. 2012 Jun;26(3):381-92. doi: 10.1007/s00540-011-1317-y. Epub 2012 Feb 17.

  PMID: 22349744 BACKGROUND

• Wei GH, Zhang J, Liao DQ, Li Z, Yang J, Luo NF, Gu Y. The common anesthetic, sevoflurane, induces apoptosis in A549 lung alveolar epithelial cells. Mol Med Rep. 2014 Jan;9(1):197-203. doi: 10.3892/mmr.2013.1806. Epub 2013 Nov 18.

  PMID: 24248633 BACKGROUND

• Liang H, Yang CX, Zhang B, Wang HB, Liu HZ, Lai XH, Liao MJ, Zhang T. Sevoflurane suppresses hypoxia-induced growth and metastasis of lung cancer cells via inhibiting hypoxia-inducible factor-1alpha. J Anesth. 2015 Dec;29(6):821-30. doi: 10.1007/s00540-015-2035-7. Epub 2015 May 23.

  PMID: 26002230 BACKGROUND

• Muller-Edenborn B, Roth-Z'graggen B, Bartnicka K, Borgeat A, Hoos A, Borsig L, Beck-Schimmer B. Volatile anesthetics reduce invasion of colorectal cancer cells through down-regulation of matrix metalloproteinase-9. Anesthesiology. 2012 Aug;117(2):293-301. doi: 10.1097/ALN.0b013e3182605df1.

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• Enlund M, Berglund A, Andreasson K, Cicek C, Enlund A, Bergkvist L. The choice of anaesthetic--sevoflurane or propofol--and outcome from cancer surgery: a retrospective analysis. Ups J Med Sci. 2014 Aug;119(3):251-61. doi: 10.3109/03009734.2014.922649. Epub 2014 May 26.

  PMID: 24857018 BACKGROUND

• Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936.

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MeSH Terms

Conditions

Neoplasms; Respiratory Aspiration

Interventions

Sevoflurane; Inhalation; Propofol; Injections

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: April 1, 2015
• Primary Completion: September 30, 2022
• Study Completion: March 30, 2023
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)