Clinical trial

Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial

Name

2016-1188

Description

A retrospective study showed that intraoperative dexmedetomidine administration was associated with decreased risk of 1-year mortality after cardiac surgery. In a previous randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized to receive either perioperative dexmedetomidine or placebo (normal saline) administration. The purpose of this 6-year follow-up study is to investigate whether perioperative dexmedetomidine can improve long-term outcomes in those recruited elderly patients after cardiac surgery.

Trial arms

Trial start

2016-12-05

Estimated PCD

2022-05-03

Trial end

2022-05-03

Status

Completed

Treatment

dexmedetomidine hydrochloride for injection

Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml). Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of \[0.1\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery. After surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation.

Arms:

DEX group

Other names:

Aibeining (trade name)

0.9% sodium chloride for injection

Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared. Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes, followed by continuous infusion at a rate of \[0.1\*kg\] ml/h until the end of surgery. After surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h and continued until the end of mechanical ventilation.

Arms:

CTRL group

Other names:

Normal saline

Size

285

Primary endpoint

Overall survival after surgery

Up to 6 years after surgery

Eligibility criteria

Inclusion Criteria: 1. Age of 60 years or older; 2. Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve replacement surgery); 3. Provide written informed consents. Exclusion Criteria: Patients who meet any of the following criteria will be excluded. 1. Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia; 2. Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier; 3. History of brain injury or neurosurgery; 4. Preoperative sick sinus syndrome, severe bradycardia (HR \< 50 bpm), second-degree or above atrioventricular block without pacemaker; 5. Severe hepatic dysfunction (Child-Pugh class C); 6. Severe renal dysfunction (requirement of renal replacement therapy); 7. Other conditions that are considered unsuitable for participation.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 285, 'type': 'ACTUAL'}}

Updated at

2023-10-31

1 organization

2 products

5 indications

Organization

Peking University First Hospital

Product

Dexmedetomidine

Indication

Cardiac surgery

Indication