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Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04209218
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
Surgery is the front-line therapy for non-small cell lung cancer (NSCLC) but postoperative complications remains high and patients' long-term outcome is still challenging. In addition to surgery, anesthetic management particularly intraoperative blood pressure management and use of dexamethasone may affect patients' early and long-term outcomes after surgery for NSCLC. This study aims to investigate the impact of intraoperative blood pressure management and dexamethasone administration on early and long-term outcomes in patients undergoing surgery for lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Surgery Blood Pressure Management Dexamethasone Overall Survival Postoperative Complications Drug: Dexamethasone Other: Targeted blood pressure management Drug: Placebo Other: Routine blood presure management Not Applicable

Detailed Description:

Surgical resection is the main treatment for patients with non-small cell lung cancer (NSCLC) and continuous efforts have been made to evolve surgical strategies and techniques. It has been now been realized that perioperative period is characterized with profound changes and anesthesia management may also affect outcomes of patients after cancer surgery.

Even under well controlled conditions, blood pressure fluctuation frequently occurs during anesthesia and surgery. In previous studies, intraoperative hypotension was associated with increased risk of organ injuries (such as delirium, acute kidney injury, myocardial injury, and stroke) and higher 1-year mortality. Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery. In a recent trial, individualized intraoperative blood pressure management which avoided intraoperative hypotension decreased the incidence of postoperative organ injury when compared with routine practice. Avoiding intraoperative hypotension may also prolong survival after lung cancer surgery. However, evidences are lacking regarding this topic.

Dexamethasone is frequently used for prevention of postoperative nausea and vomiting. Studies showed that a single low-dose dexamethasone has anti-inflammatory effect and can regulate immune function. It has been shown that perioperative dexamethasone can improve analgesia after surgery. In retrospective studies, perioperative low-dose dexamethasone was associated with less wound infection and improved long-term survival in patients after surgeries for pancreatic and lung cancer. It is hypothesized that intraoperative dexamethasone may reduce postoperative complications and improve long-term survival after lung cancer surgery. Interventional studies are required to confirm this hypothesis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1988 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A 2 × 2 factorial randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.
Primary Purpose: Prevention
Official Title: Impact of Intraoperative Blood Pressure Management and Dexamethasone on Patient's Outcomes After Lung Cancer Surgery: A 2 × 2 Factorial Randomized Controlled Trial
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Placebo Comparator: Routine blood pressure management + placebo
Blood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.
Drug: Placebo
Placebo (2 ml normal saline) is administered before anesthesia induction.
Other Name: Normal saline

Other: Routine blood presure management
Blood pressure is maintained according to routine practice.

Experimental: Routine blood pressure management + dexamethasone
Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.
Drug: Dexamethasone
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Other Name: Glucocorticoids

Other: Routine blood presure management
Blood pressure is maintained according to routine practice.

Experimental: Targeted blood pressure management + placebo
Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.
Other: Targeted blood pressure management
Blood pressure is maintained within ±10% from baseline.

Drug: Placebo
Placebo (2 ml normal saline) is administered before anesthesia induction.
Other Name: Normal saline

Experimental: Targeted blood pressure management + dexamethasone
Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Drug: Dexamethasone
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Other Name: Glucocorticoids

Other: Targeted blood pressure management
Blood pressure is maintained within ±10% from baseline.




Primary Outcome Measures :
  1. Overall survival within 3 years after surgery [ Time Frame: Up to 3 years after surgery ]
    Overall survival within 3 years after surgery

  2. Incidence of postoperative complications within 30 days (substudy) [ Time Frame: Up to 30 days after surgery ]
    Postoperative complications are generally defined as newly occurred medical conditions that are harmful to patients' recovery and required interventional therapy; including but not limited to delirium, acute kidney injury, myocardial injury, and other complications after surgery.


Secondary Outcome Measures :
  1. Recurrence-free survival within 3 years after surgery [ Time Frame: Up to 3 years after surgery ]
    Recurrence-free survival within 3 years after surgery

  2. Cancer-specific survival within 3 years after surgery [ Time Frame: Up to 3 years after surgery ]
    Cancer-specific survival within 3 years after surgery

  3. Quality of life of 1-year survivors [ Time Frame: At the end of the 1st year after surgery ]
    Quality of life is assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-30, score ranges from 0 to 100, with higher score indicating better function) and Quality of Life Questionnaire Lung Cancer-13 (QLQ LC-13, score ranges from 0 to 100, with higher score indicating better function).

  4. Incidence of organ injury and other complications within 5 days after surgery (substudy) [ Time Frame: Up to 5 days after surgery ]
    A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery

  5. Rate of admission to the intensive care unit after surgery (substudy) [ Time Frame: Up to 30 days after surgery ]
    Admission to the intensive care unit after surgery

  6. Length of stay in the intensive care unit after surgery (substudy) [ Time Frame: Up to 30 days after surgery ]
    Length of stay in the intensive care unit after surgery

  7. Length of stay in hospital after surgery (substudy) [ Time Frame: Up to 30 days after surgery ]
    Length of stay in hospital after surgery

  8. Rate of 30-day all-cause mortality (substudy) [ Time Frame: Up to 30 days after surgery ]
    Death due to any cause within 30 days after surgery


Other Outcome Measures:
  1. Pain score within 3 days after surgery (substudy) [ Time Frame: Up to 3 days after surgery ]
    Pain score is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain.

  2. Subjective sleep quality score within 3 days after surgery (substudy) [ Time Frame: Up to 3 days after surgery ]
    Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged >50 years but <90 years.
  • Diagnosed as resectable primary non-small cell lung cancer (stage IA-IIIA) and scheduled for radical surgery with an expected duration of >2 hours.
  • Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

  • Clinical examinations suggest non-resectable lung cancer or patients scheduled for a biopsy surgery.
  • Recurrent or metastatic lung cancer.
  • History of cancer or complicated with cancer in other organs.
  • Long-term exposure to glucocorticoids or other immunosuppressant(s) due to autoimmune disease or organ transplantation.
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg); or requirement of vasopressors to maintain blood pressure.
  • Persistent atrial fibrillation, or acute cardiovascular events (acute coronary syndrome, stroke, or congestive heart failure) within 3 months.
  • Severe hepatic dysfunction (Child-Pugh C) or renal failure (requirement of renal replacement therapy).
  • Any other circumstances considered unsuitable for study participation by attending physicians or investigators.

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): NCT04209218


Contacts
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Contact: Dong-Xin Wang, MD, PhD 86 (10) 83572784 wangdongxin@hotmail.com
Contact: Wen-Wen Huang, MD 86 (10) 83572460 hww9215@163.com

Locations
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China, Beijing
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    86 (10) 83572784    wangdongxin@hotmail.com   
Contact: Yi-Bin Hua, MD    86 (10) 83572460    huayibin@126.com   
Sub-Investigator: Wen-Wen Huang, MD         
Principal Investigator: Dong-Xin Wang, MD, PhD         
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04209218    
Other Study ID Numbers: 2019-234
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Lung Cancer
Radical Resection
Blood Pressure Management
Dexamethasone
Overall Survival
Postoperative Complications
Additional relevant MeSH terms:
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Lung Neoplasms
Postoperative Complications
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Dexamethasone
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents