Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.

Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.

Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.

Study Overview

• Status: Completed
• Conditions: Delirium; Postoperative Confusion
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 864
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China
      • Anqing Municipal Hospital
    • Bengbu, Anhui, China
      • Affiliated Hospital of Bengbu Medical College
    • Chaohu, Anhui, China
      • Affiliated Chaohu Hospital of Anhui Medical Hospital
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • Binhu Hospital of Hefei
    • Hefei, Anhui, China
      • Second Affiliated hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The first Hospital of Hefei
    • Hefei, Anhui, China
      • The Second Hospital of Hefei
    • Hefei, Anhui, China
      • The Second People's Hospital of Anhui
    • Liuan, Anhui, China
      • the people's Hospital of Liuan
    • Tongling, Anhui, China
      • the people's Hospital of Tongling
    • Wuhu, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
    • Wuhu, Anhui, China
      • The second People's Hospital of Wuhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent
2. Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
3. Age 65-90 yrs；
4. Anesthesia Society of American (ASA) Scale II~III；
5. Anticipated surgery time 2-6 hrs； -

Exclusion Criteria:

1. Dementia patients（Mini-mental state examination< 20）
2. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
3. Unstable metal status and mental disease；
4. The cognitive function examination in 3-6 months is not anticipated to be completed
5. II-III Atrioventricular block；
6. Heat rate < 50 beats/minutes；
7. Parkinson's Disease；
8. May occur or have occurred the difficult airway or anticipated delayed extubation
9. Sure or suspected abuse of analgesic and sedation drug；
10. Allergic to the trial drug and other anesthesia drug contraindication； -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.	Drug: Dexmedetomidine; 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.; Other Names: Yisi
Placebo Comparator: Controlled; 0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.	Drug: Saline; 0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of incidence of postoperative cognition dysfunction	The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively.; A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min.; Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference.; Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation（SD）of the difference of the normal population, that is ΔX / SD and it is the Z score.; POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.	1 day Before surgery,the 3rd,7th day after the surgery.
The change of incidence of postoperative delirium	Through CAM-ICU to assess the incidence of the postoperative delirium.	The first, second and third day after the surgery.
The change of Neuropsychological status	Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.	the 3rd,6th month after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of cardiovascular events.		from begging of the anesthesia to the time the patients discharge, up to 1 month.
The incidence of any adverse or severe adverse events.	Including kidney or brain related adverse events.	From the beginning of the admitted to 6 month after the surgery, up to 6 month.
The variation of heart rate.	Heart rate is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
The variation of blood pressure.	blood pressure is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
the variation of pulse oxygen saturation.	Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
The monitor of depth of anesthesia.	Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
The serum concentrations of BDNF	Serum level of brain-derived neurotrophic factor (BDNF) was measured	From the baseline to the 3-day,7-day and 1-month.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Investigators: Principal Investigator: Wei Er Gu, The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 20, 2017

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Dexmedetomidine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Confusion; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 201401 (Other Grant/Funding Number: The research fund of Fuda cancer hospital in Guangzhou)