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Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923128
Recruitment Status : Unknown
Verified October 2016 by Zhejiang Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 4, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Brief Summary:
The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Postoperative Delirium Drug: Dexmedetomidine Drug: Sufentanyl Drug: Saline Phase 4

Detailed Description:
  1. collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 150 elder patients (age ≥65 years) routine tumor surgery, American Society of Anesthesiologists classification-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.
  2. Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 75 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: fentanyl 100ug + dexmedetomidine 150 ug, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: fentanyl 150ug, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program. Venous blood serum is taken before surgery, at the before end of surgery and when postoperative analgesia medication runs out (postoperative day 4) to test apolipoprotein E, Amyloid-β1-42, Amyloid-β1-40, N-terminal pro B-type natriuretic peptide.
  3. Post operative delirium and postoperative cognitive dysfunction diagnosis: Patients completed neuropsychological tests at entry to the study-generally the day before surgery-and at discharge from hospital or 1 week. The investigators assessed delirium by the Confusion Assessment Method for the intense care unit. The neuropsychological tests include Wechsler Adult Intelligence Scale-Revised by China Visual Reproduction、Wechsler Adult Intelligence Scale-Revised by China Digit Span、Digit-Symbol Substitution Test、The Stroop Color-Word Test、Trail Making Test A and Trail Making Test B. Patients had cognitive dysfunction when two Z scores in individual tests or the combined Z score were 1.96 or more.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Dexmedetomidine+routine PCIA
Dexmedetomidine 150ug is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.Routine patient controlled intravenous analgesia(PCIA) formula is sufentanyl(0.06ug.kg-1.h-1),diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Drug: Dexmedetomidine
Dexmedetomidine 150ug is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Other Name: Dexmedetomidine Hydrochloride Injection

Drug: Sufentanyl
Sufentanyl(0.06ug.kg-1.h-1) is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Other Name: Sufentanil Citrate Injection

Drug: Saline
Saline is used to dilute other drugs
Other Name: normal saline,physiological saline,NS

Sham Comparator: Routine PCIA
Routine patient controlled intravenous analgesia(PCIA) formula is sufentanyl(0.06ug.kg-1.h-1),diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Drug: Sufentanyl
Sufentanyl(0.06ug.kg-1.h-1) is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Other Name: Sufentanil Citrate Injection

Drug: Saline
Saline is used to dilute other drugs
Other Name: normal saline,physiological saline,NS




Primary Outcome Measures :
  1. Incidence of postoperative cognitive dysfunction [ Time Frame: 7 days after surgery ]

Secondary Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: 3 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients' age ≥65 years
  • Underwent elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

  • Patients with severe bradycardia (heart rate<55bpm)
  • Severe arrhythmia or cardiac dysfunction (ejection fraction<35%)
  • Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
  • Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
  • History of alcohol abuse or a history of drug dependence
  • Have brain surgery or trauma
  • Severe vision or hearing impairment
  • Cannot with the completion of tests of cognitive function
  • Refused to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923128


Contacts
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Contact: Kangjie Xie, MD 008613516721870 xkj1243@163.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT02923128    
Other Study ID Numbers: 2015-01-13
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Delirium
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Sufentanil
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General