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

NCT02275182 | Completed Phase 4 DMC

• 1 other identifier: 201401
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Postoperative Confusion; Delirium

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• The change of incidence of postoperative cognition dysfunction

  1. The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively. 2. A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min. 3. 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. 4. 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. 5. 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 Outcomes (7)

• 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.

  From the beginning of the admitted to 6 month after the surgery, up to 6 month.

• The variation of heart rate.

  From the beginning to the end of anesthesia,up to 6 hours.

• The variation of blood pressure.

  From the beginning to the end of anesthesia,up to 6 hours.

• the variation of pulse oxygen saturation.

  From the beginning to the end of anesthesia,up to 6 hours.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Controlled

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Also known as: Yisi

Dexmedetomidine

Saline DRUG

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.

Controlled

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (13)

Anqing Municipal Hospital

Anqing, Anhui, China

Location

Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Affiliated Chaohu Hospital of Anhui Medical Hospital

Chaohu, Anhui, China

Location

Binhu Hospital of Hefei

Hefei, Anhui, China

Location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The first Hospital of Hefei

Hefei, Anhui, China

Location

The Second Hospital of Hefei

Hefei, Anhui, China

Location

The Second People's Hospital of Anhui

Hefei, Anhui, China

Location

the people's Hospital of Liuan

Liuan, Anhui, China

Location

the people's Hospital of Tongling

Tongling, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

The second People's Hospital of Wuhu

Wuhu, Anhui, China

Location

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wei Er Gu

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Department

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: February 20, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

CN (13)