Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients

August 21, 2014 updated by: Ma Zhengmin, First Affiliated Hospital Xi'an Jiaotong University

Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study

The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Elective gastrointestinal surgery
  • American Society of Anesthesiologists class II to III
  • Aged between 65 and 80 years old
  • Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2
  • With primary hypertension reaching or more than 1 year
  • Normal cognitive function,mini-mental state examination more than 27

Exclusion Criteria:

  • Severe arrhythmia,atrioventricular block and secondary hypertension
  • Liver and kidney dysfunction,pulmonary disease,endocrine disease
  • Suspected or confirmed difficult airway
  • Any disease or pathologic change will interfere study result
  • Inability to exchange with serious visual and hearing impairment
  • Long term use of sedative-hypnotic drugs and antidepressant drug
  • Addicted to alcohol, tobacco or drug
  • Neuromuscular disease
  • Suspected of malignant hyperthermia
  • Allergic to investigational products or with other contraindication
  • Participated in other study within 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A, dexmedetomidine , 0.3µg.kg-1.h-1
Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
Drug: dexmedetomidine
Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
Drug: dexmedetomidine
Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate
Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane
Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
Experimental: Group B,dexmedetomidine , 0.5µg.kg-1.h-1
Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
Drug: dexmedetomidine
Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
Drug: dexmedetomidine
Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate
Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane
Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
Placebo Comparator: Group C ,normal saline
Normal saline infusion will be given with the same infusion volume as group A and B
Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate
Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane
Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
Drug: normal saline
Group C , Normal saline infusion will be given with the same infusion volume as group A and B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to postoperation in cognitive function
Time Frame: One day before operation,third day after operation,sixth day after operaion
Mini-mental State Examination
One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in recent memory
Time Frame: One day before operation,third day after operation,sixth day after operation
Rey Auditory Verbal Learning Test
One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in visual space and directional force
Time Frame: One day before operation,third day after operation,sixth day after operaion
Trail Making Test A,Trail Making Test B
One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in attention
Time Frame: One day before operation,third day after operation,sixth day after operaion
Digit Span Test
One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in pain scores
Time Frame: One day before operation,third day after operation,sixth day after operation
Visual analog scales
One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in depression scale
Time Frame: One day before operation,third day after operation,sixth day after operation
Beck Depression Inventory
One day before operation,third day after operation,sixth day after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The duration of operation
Time Frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The blood volume during the operation
Time Frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The urine volume during operation
Time Frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of drugs used during operation
Time Frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of ephedrine, urapidil, atropine used during operation
From begining of cutting skin to the end of skin closure,an expected average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ma sedation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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