Dexmedetomidine supplemented analgesia for delirium and prolong survival after surgrey

JRCT ID: jRCTs021200016

Registered date:13/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Postoperative patients
• Date of first enrollment: 13/08/2020
• Target sample size: 1600
• Countries of recruitment: China,Japan
• Study type: Interventional

Intervention(s)

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 PCA pump (bolus dose 2 ml, lockout interval 8 min)
Placebo group. The morphine solution in normal saline (0.5 mg/ml, total 160ml) will be intravenously infused at a rate of 1ml/h as a PCA pump (bolus dose 2 ml, lock-out interval 8 min)

Outcome(s)

• Primary Outcome: Frequency of delirium within the first 5 days after surgery.

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 64age old
• Age maximum: < 90age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hirota Kazuyoshi
• Source(s) of Monetary Support: Funding of department of anesthesiology