Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

NCT ID: NCT04209218

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1988 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-07

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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

Conditions

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Lung Cancer Surgery Blood Pressure Management Dexamethasone Overall Survival Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A 2 × 2 factorial randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.

Study Groups

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Routine blood pressure management + placebo

Blood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (2 ml normal saline) is administered before anesthesia induction.

Routine blood presure management

Intervention Type OTHER

Blood pressure is maintained according to routine practice.

Routine blood pressure management + dexamethasone

Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Routine blood presure management

Intervention Type OTHER

Blood pressure is maintained according to routine practice.

Targeted blood pressure management + placebo

Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.

Group Type EXPERIMENTAL

Targeted blood pressure management

Intervention Type OTHER

Blood pressure is maintained within ±10% from baseline.

Placebo

Intervention Type DRUG

Placebo (2 ml normal saline) is administered before anesthesia induction.

Targeted blood pressure management + dexamethasone

Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Targeted blood pressure management

Intervention Type OTHER

Blood pressure is maintained within ±10% from baseline.

Interventions

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Dexamethasone

Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Intervention Type DRUG

Targeted blood pressure management

Blood pressure is maintained within ±10% from baseline.

Intervention Type OTHER

Placebo

Placebo (2 ml normal saline) is administered before anesthesia induction.

Intervention Type DRUG

Routine blood presure management

Blood pressure is maintained according to routine practice.

Intervention Type OTHER

Other Intervention Names

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Glucocorticoids Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Chairman, Department of Anaesthesiology and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong-Xin Wang, MD, PhD

Role: CONTACT

86 (10) 83572784

Wen-Wen Huang, MD

Role: CONTACT

86 (10) 83572460

Facility Contacts

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Dong-Xin Wang, MD, PhD

Role: primary

86 (10) 83572784

Yi-Bin Hua, MD

Role: backup

86 (10) 83572460

References

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Other Identifiers

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2019-234

Identifier Type: -

Identifier Source: org_study_id

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