Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery
Ključne besede
Povzetek
Opis
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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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.
Datumi
| Nazadnje preverjeno: | 05/31/2020 |
| Prvič predloženo: | 12/16/2019 |
| Predviden vpis oddan: | 12/18/2019 |
| Prvič objavljeno: | 12/23/2019 |
| Zadnja posodobitev oddana: | 06/01/2020 |
| Zadnja posodobitev objavljena: | 06/03/2020 |
| Dejanski datum začetka študija: | 04/06/2020 |
| Predvideni datum primarnega zaključka: | 11/30/2023 |
| Predvideni datum zaključka študije: | 11/30/2026 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Dexamethasone
Other: Targeted blood pressure management
Drug: Placebo
Other: Routine blood presure management
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| 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. | |
| Experimental: Routine blood pressure management + dexamethasone Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction. | |
| Experimental: Targeted blood pressure management + placebo Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction. | |
| Experimental: Targeted blood pressure management + dexamethasone Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction. |
Merila upravičenosti
| Starost, primerna za študij | 50 Years Za 50 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. Overall survival within 3 years after surgery [Up to 3 years after surgery]
2. Incidence of postoperative complications within 30 days (substudy) [Up to 30 days after surgery]
Ukrepi sekundarnega rezultata
1. Recurrence-free survival within 3 years after surgery [Up to 3 years after surgery]
2. Cancer-specific survival within 3 years after surgery [Up to 3 years after surgery]
3. Quality of life of 1-year survivors [At the end of the 1st year after surgery]
4. Incidence of organ injury and other complications within 5 days after surgery (substudy) [Up to 5 days after surgery]
5. Rate of admission to the intensive care unit after surgery (substudy) [Up to 30 days after surgery]
6. Length of stay in the intensive care unit after surgery (substudy) [Up to 30 days after surgery]
7. Length of stay in hospital after surgery (substudy) [Up to 30 days after surgery]
8. Rate of 30-day all-cause mortality (substudy) [Up to 30 days after surgery]
Drugi izidni ukrepi
1. Pain score within 3 days after surgery (substudy) [Up to 3 days after surgery]
2. Subjective sleep quality score within 3 days after surgery (substudy) [Up to 3 days after surgery]
