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Impact of Anesthesia Maintenance Methods on Long-term Survival Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660411
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
Hebei Medical University Fourth Hospital
The People's Hospital of Ningxia
Peking University Hospital of Stomatology
Beijing Cancer Hospital
Beijing Shijitan Hospital
Guizhou Provincial People's Hospital
Affiliated Hospital of Qinghai University
The Third Xiangya Hospital of Central South University
Cancer Hospital of Guangxi Medical University
Shaanxi Provincial People's Hospital
Zhongda Hospital
The First Affiliated Hospital of Zhengzhou University
Tang-Du Hospital
Shanxi Province Cancer Hospital
Tianjin Nankai Hospital
Shenzhen Second People's Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
Surgery is one of the major treatment methods for patients with malignant tumor. And, alone with the ageing process, more and more elderly patients undergo surgery for malignant tumor. 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.

Condition or disease Intervention/treatment Phase
Long-term Effects Secondary to Cancer Therapy in Adults Drug: Sevoflurane Drug: Propofol Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Inhalational Versus Intravenous Anesthesia Maintenance Methods on Long-term Survival Rate in Elderly Patients After Cancer Surgery: an Open-label, Randomized Controlled Trial
Actual Study Start Date : April 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sevoflurane group

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, with or without 50% nitrous oxide. 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
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, with or without 50% nitrous oxide. Sevoflurane inhalational concentration will be decreased towards the end of surgery. Sevoflurane inhalation will be stopped at the end of surgery.
Other Name: Sevoflurane for inhalation

Experimental: Propofol group

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, with or without 50% nitrous oxide. 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
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, with or without 50% nitrous oxide. Propofol infusion rate will be decreased towards the end of surgery. Propofol infusion will be stopped at the end of surgery.
Other Name: Propofol for injection




Primary Outcome Measures :
  1. 3-year survival after surgery [ Time Frame: Until the end of the 3rd year after surgery ]
    Duration of survival within 3 years after surgery


Secondary Outcome Measures :
  1. Survival rates at different timepoints after surgery [ Time Frame: At the 1st, 2nd, and 3rd year after surgery ]
    Survival rates at different timepoints after surgery

  2. 3-year recurrence-free survival after surgery [ Time Frame: Until the end of the 3rd year after surgery ]
    Duration of recurrence-free survival within 3 years after surgery

  3. Recurrence-free survival rates at different timepoints after surgery [ Time Frame: At the 1st, 2nd, and 3rd year after surgery ]
    Recurrence-free survival rates at different timepoints after surgery

  4. Quality of life of survivors at 3 years after surgery [ Time Frame: Assessed at the end of the 3rd year after surgery ]
    Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  5. Cognitive function of survivors at 3 years after surgery [ Time Frame: Assessed at the 3rd year after surgery ]
    Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m)



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be included if they meet all the following criteria:

    1. Age ≥ 65 years and < 90 years;
    2. Primary malignant tumor;
    3. Do not receive radiation therapy or chemotherapy before surgery;
    4. Scheduled to undergo surgery for the treatment of tumors, with an expected duration of 2 hours or more, under general anesthesia;
    5. Agree to participate, and give signed written informed consent.

Exclusion Criteria:

  • Patients will be excluded if they meet any of the following criteria:

    1. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
    2. Inability to communicate in the preoperative period (coma, profound dementia, language barrier, or end-stage disease);
    3. 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);
    4. Neurosurgery;
    5. Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660411


Locations
Show Show 17 study locations
Sponsors and Collaborators
Peking University First Hospital
Hebei Medical University Fourth Hospital
The People's Hospital of Ningxia
Peking University Hospital of Stomatology
Beijing Cancer Hospital
Beijing Shijitan Hospital
Guizhou Provincial People's Hospital
Affiliated Hospital of Qinghai University
The Third Xiangya Hospital of Central South University
Cancer Hospital of Guangxi Medical University
Shaanxi Provincial People's Hospital
Zhongda Hospital
The First Affiliated Hospital of Zhengzhou University
Tang-Du Hospital
Shanxi Province Cancer Hospital
Tianjin Nankai Hospital
Shenzhen Second People's Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02660411    
Other Study ID Numbers: 2015[869]-2
ChiCTR-IPR-15006209 ( Registry Identifier: Chinese Clinical Trial Registry (www.chictr.org.cn) )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Sevoflurane
Propofol
Aged
Neoplasm
Surgical Procedure, Operative
Long-term survival
Additional relevant MeSH terms:
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Nitrous Oxide
Anesthetics
Propofol
Benzocaine
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics