Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
Impact of Perioperative Dexmedetomidine on Long-term Survival in Older Patients After Cancer Surgery: a Multicenter Randomized Trial
Peking University First Hospital
4,532 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
Summary
Along with aging population, cancer incidence and mortality are increasing. However, despite advances in oncology and surgery, long-term survival of cancer patients is far from optimal. Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative, analgesic, and anxiolytic effects. Studies showed that perioperative use of dexmedetomidine reduces delirium and some non-delirium complications after surgery. In long-term follow-up studies of older patients who, for other reasons, were randomized to receive either dexmedetomidine or placebo during intra- or postoperative period, dexmedetomidine use was associated with improved long-term survival. This multicenter randomized trial aims to investigate the effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing cancer surgery.
Eligibility
Inclusion Criteria3
- Aged 60 years or older.
- Scheduled to undergo radical surgery for cancer under general anesthesia, with an expected surgical duration of 2 hours or longer.
- Required patient-controlled intravenous analgesia after surgery.
Exclusion Criteria6
- Inability to communicate preoperatively due to visual, auditory, verbal. or other reasons.
- Surgery for breast cancer or intracranial tumor.
- Preoperative severe sinus bradycardia (<50 beats per minute), sick sinus syndrome，or second-degree or above atrioventricular block without pacemaker.
- Severe hepatic dysfunction (Child-Pugh class C).
- Severe renal dysfunction (requirement of renal replacement therapy before surgery).
- Enrolled in other clinical studies.
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Interventions
A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Locations(39)
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NCT06030804