Clinical trial

Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial

Name

2016-10-LT

Description

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen long-term outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may help to maintain immune function and improve long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

Trial arms

Trial start

2017-01-06

Estimated PCD

2022-05-12

Trial end

2024-05-01

Status

Active (not recruiting)

Treatment

Dexmedetomidine supplemented morphine analgesia

Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.

Arms:

Dexmedetomidine group

Morphine analgesia

Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.

Arms:

Control group

Size

1500

Primary endpoint

Overall survival after surgery

Up to 7 years after surgery

Eligibility criteria

Inclusion Criteria: * Age \>= 65 years, \< 90 years; * Scheduled to undergo surgery for primary solid organ cancer under general anesthesia, with an expected duration of surgery \>=2 hours; * Planned to use patient-controlled intravenous analgesia after surgery; * Provide written informed consent. Exclusion Criteria: * Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis; * Preoperative radio- or chemotherapy; * Inability to communicate in the preoperative period because of coma, profound dementia or language barrier; * Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score \>= 3); * Brain trauma or neurosurgery; * 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; * Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery); * ASA classification \>= IV.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1500, 'type': 'ACTUAL'}}

Updated at

2023-08-01

1 organization

2 products

5 indications

Organization

Peking University First Hospital

Product

Dexmedetomidine supplemented morphine analgesia

Indication

Elderly

Indication