Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugA 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.
Placebo
DrugVolume-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.
Treatment groups
4,532 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival after surgery
Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.
Time frame
Up to 3 years after surgery of the last enrolled patient.Secondary outcomes
1
Incidence of postoperative delirium.
Delirium will be assessed with the 3D-Confusion Assessment Method (3D-CAM) or CAM for the Intensive Care Unit (CAM-ICU) twice daily during the first 4 postoperative days.
Time frame
During the first 4 postoperative days.2
Incidence of cognitive dysfunction at 6 months and 1 year postoperatively.
Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 6 months and 12 months after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline will be considered occurrence of cognitive dysfunction.
Time frame
At 6 months and 1 year postoperatively.Other outcomes
1
Rate of intensive care unit (ICU) admission after surgery.
Percentage of patients who required ICU admission within 30 days after surgery.
Time frame
Up to 30 days after surgery.2
Intensity of pain after surgery.
Intensity of pain will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily during the first 4 postoperative days.
Time frame
Two hours after surgery and during the first 4 postoperative days.3
Subjective sleep quality after surgery.
Subjective sleep quality will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily during the first 4 postoperative days.
Time frame
During the first 4 postoperative days.4
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Time frame
Up to 30 days after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University
Collaborator
Source ClinicalTrials.gov