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

Not Applicable

• Conditions: Elderly Patients; Non-cardiac Surgery
• Interventions: Procedure: limb remote ischemic preconditioning(LRIP)

• Registration Number: NCT03028389
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23
• Study Start: 2017-02-01
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 611

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limb RIPC	limb remote ischemic preconditioning(LRIP)	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.

Primary Outcome Measures

Name	Time	Method
the incidence of delirium	in the first 7 days after surgery