Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery (LRIP-D)

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Non-cardiac Surgery; Elderly Patients

Treatments: Procedure: limb remote ischemic preconditioning(LRIP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03028389

LRIP20170116

Details and patient eligibility

About

To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.

Full description

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.

Enrollment: 611 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elderly patients received elective non-cardiac surgery with general anesthesia
• anticipated surgery time > 2 hours

Exclusion criteria

• age < 65 years old
• Acute coronary syndrome or myocardial infraction within 3 months
• Chronic obstructive pulmonary emphysema
• Serious hepatic dysfunction (Child-Pugh class C)
• serious renal dysfunction (undergoing dialysis before surgery)
• Ejection fraction less than 40%
• Poor pulmonary function (PaO2 <60mmHg)
• Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
• Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
• Brain injury or neurosurgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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611 participants in 2 patient groups

Limb RIPC

Experimental group

Description:

The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.

Treatment:

Procedure: limb remote ischemic preconditioning(LRIP)

Convention

No Intervention group

Description:

Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia