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

Elderly Patients Clinical Trial

— LRIP-D  

Official title:

Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03028389
• Other study ID #: LRIP20170116
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2017
• Last updated: January 19, 2017
• Start date: February 1, 2017
• Est. completion date: February 2017

Study information

• Verified date: January 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jian Liu, MD
• Phone: +86-15013228487
• Email: launfyy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 611
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Elderly Patients
• Non-cardiac Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of delirium		in the first 7 days after surgery