Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

August 8, 2022 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Intraoperative Blood Pressure Management and Dexamethasone on Patient's Outcomes After Lung Cancer Surgery: A 2 × 2 Factorial Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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.

Study Type

Interventional

Enrollment (Anticipated)

1988

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen-Wen Huang, MD
  • Phone Number: 86 (10) 83572460
  • Email: hww9215@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
        • Contact:
        • Sub-Investigator:
          • Wen-Wen Huang, MD
        • Principal Investigator:
          • Dong-Xin Wang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.
Other: Routine blood presure management
Blood pressure is maintained according to routine practice.
Drug: Dexamethasone
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Other Names:
  • Glucocorticoids
Experimental: Targeted blood pressure management + placebo
Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.
Drug: Placebo
Placebo (2 ml normal saline) is administered before anesthesia induction.
Other Names:
  • Normal saline
Other: Targeted blood pressure management
Blood pressure is maintained within ±10% from baseline.
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 Names:
  • Glucocorticoids
Other: Targeted blood pressure management
Blood pressure is maintained within ±10% from baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after surgery
Time Frame: Up to 5 years after surgery
Overall survival after surgery
Up to 5 years after surgery
Incidence of organ injury and complications within 5 days after surgery (sub-study).
Time Frame: Up to 5 days after surgery.
Organ injury includes delirium, acute kidney injury and myocardial injury. Postoperative complications are generally defined as newly occurred medical conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
Up to 5 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival after surgery
Time Frame: Up to 5 years after surgery
Recurrence-free survival after surgery
Up to 5 years after surgery
Cancer-specific survival after surgery
Time Frame: Up to 5 years after surgery
Cancer-specific survival after surgery
Up to 5 years after surgery
Event-free survival after surgery
Time Frame: Up to 5 years after surgery
Event-free survival after surgery
Up to 5 years after surgery
Rate of intensive care unit (ICU) admission after surgery (sub-study)
Time Frame: During the day of surgery
Rate of ICU admission after surgery
During the day of surgery
Rate of ICU admission with endotracheal intubation after surgery (sub-study)
Time Frame: During the day of surgery
Rate of ICU admission with endotracheal intubation after surgery
During the day of surgery
Duration of mechanical ventilation in ICU after surgery (sub-study)
Time Frame: Up to 30 days after surgery
Duration of mechanical ventilation in ICU after surgery
Up to 30 days after surgery
Length of stay in ICU after surgery (sub-study)
Time Frame: Up to 30 days after surgery
Length of stay in ICU after surgery
Up to 30 days after surgery
Incidence of organ injury within 5 days after surgery (sub-study)
Time Frame: Up to 5 days after surgery
Organ injury includes delirium, acute kidney injury and myocardial injury. Delirium is assessed with the 3-minute diagnostic assessment for CAM-defined delirium (3D-CAM). Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Myocardial injury is diagnosed according to the serum cardiac troponin I level (higher than upper normal limit of the hospital's clinical laboratory).
Up to 5 days after surgery
Incidence of complications within 30 days after surgery (sub-study)
Time Frame: Up to 30 days after surgery
Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
Up to 30 days after surgery
Length of stay in hospital after surgery (sub-study)
Time Frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Up to 30 days after surgery
Rate of 30-day all-cause mortality (sub-study)
Time Frame: Up to 30 days after surgery
Death due to any cause within 30 days after surgery
Up to 30 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after surgery in cancer patients
Time Frame: Up to 5 years after surgery
Overall survival after surgery in cancer patients
Up to 5 years after surgery
Recurrence-free survival after surgery in cancer patients
Time Frame: Up to 5 years after surgery
Recurrence-free survival after surgery in cancer patients
Up to 5 years after surgery
Cancer-specific survival after surgery in cancer patients
Time Frame: Up to 5 years after surgery
Cancer-specific survival after surgery in cancer patients
Up to 5 years after surgery
Event-free survival after surgery in cancer patients
Time Frame: Up to 5 years after surgery
Event-free survival after surgery in cancer patients
Up to 5 years after surgery
30-item quality of life in 1-, 2-, and 3-year survivors
Time Frame: At the end of the 1st, 2nd, and 3rd year after surgery
Quality of life is assessed with the 30-item Core Quality of Life Questionnaire (QLQ-C30), which assess functioning and symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating better function or worse symptom.
At the end of the 1st, 2nd, and 3rd year after surgery
13-item quality of life in 1-, 2-, and 3-year survivors
Time Frame: At the end of the 1st, 2nd, and 3rd year after surgery
Quality of life is assessed with the 13-item Quality of Life Questionnaire-Lung Cancer Module (QLQ LC-13), which assess symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating worse symptom. The QLQ LC-13 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30.
At the end of the 1st, 2nd, and 3rd year after surgery
Pain score within 3 days after surgery (sub-study)
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.
Up to 3 days after surgery
Subjective sleep quality score within 3 days after surgery (sub-study)
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.
Up to 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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