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

NCT ID: NCT03028389

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-02-28

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.

Conditions

Elderly Patients; Non-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Limb RIPC

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.

Group Type: EXPERIMENTAL

limb remote ischemic preconditioning(LRIP)

Intervention Type: PROCEDURE

LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.

Convention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

limb remote ischemic preconditioning(LRIP)

LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.

Intervention Type: PROCEDURE

Other Intervention Names

LRIP

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kexuan Liu

Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ke-Xuan Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, the Southern Medical University

Central Contacts

Jian Liu, MD

Role: CONTACT

launfyy@126.com

+86-15013228487

Other Identifiers

LRIP20170116

Identifier Type: -

Identifier Source: org_study_id