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Dexmedetomidine supplemented analgesia for delirium and prolong survival after surgrey

Impact of dexmedetomidine supplemented analgesia on postoperative delirium and long-term survival in elderly patients after cancer surgery: A multicenter, double-blinded, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021200016
Enrollment
1600
Registered
2020-08-13
Start date
2020-08-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative patients

Interventions

Dexmedetomidine group. The mixture solution of morphine (0.5 mg/ml) and dexmedetomidine(1.25 micro g/ml) in normal saline( total volume 160 ml) will be intravenously infused at a rate of 1mlhr as a PC

Sponsors

Hirota Kazuyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Age older than 65 years, less than 90 years 2 Scheduled to undergo surgery for primary solid organ cancer under general anesthesia, with an expected duration of surgery longer than 2 hours 3 Planned to use patient-controlled intravenous analgesia (PCIA) after surgery 4 Provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded. 1 Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 2 Preoperative radio- or chemotherapy; 3 Inability to communicate in the preoperative period because of coma, profound dementia or language barrier; 4 Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or STOP-Bang scoring model score 5 Brain injury or neurosurgery; 6 Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker; 7 Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery); 8 ASA classification IV or above.

Design outcomes

Primary

MeasureTime frame
Frequency of delirium within the first 5 days after surgery.

Secondary

MeasureTime frame
1 Early outcomes 1.1 Daily frequency of delirium during the first 5 days after surgery; 1.2 Length of stay in hospital after surgery; 1.3 Incidence of non-delirium complications with 30 days after surgery; 1.4 All-cause 30-day mortality; 1.5 Quality of life of 30-day survivors: assessed with WHOQOL-BREF 1.6 Cognitive function of 30-day survivors: assessed with TICS-m 1.7 RASS sedation score during postoperative days 1-5; 1.8 Cumulative morphine consumption during postoperative days 1-5; 1.9 NRS pain score during postoperative days 1-5; 1.10 NRS score of subjective sleep quality during postoperative days 1-5. 2 Long-term outcomes 2.1 2-year survival after surgery; 2.2 Survival rates at different time-points after surgery; 2.3 2-year recurrence-free survival after surgery; 2.4 Recurrence-free survival rates at different time-points after surgery; 2.5 Quality of life in 1- and 2-year survivors after surgery (assessed with WHOQOL-BREF) 2.6 Cognitive function in 1- and 2-year survivors after surgery (assessed with TICS-m)

Countries

China, Japan

Contacts

Public ContactEiji Hashiba

Hirosaki University Hospital

ehashiba@hirosaki-u.ac.jp+81-172-39-5322

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026