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

NCT ID: NCT02224443

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Cognitive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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

midazolam,fentanyl,etomidate,Cisatracurium besylate

Intervention Type DRUG

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

cisatracurium besylate,propofol,remifentanil,sevoflurane

Intervention Type DRUG

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%

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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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

midazolam,fentanyl,etomidate,Cisatracurium besylate

Intervention Type DRUG

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

cisatracurium besylate,propofol,remifentanil,sevoflurane

Intervention Type DRUG

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%

Group C ,normal saline

Normal saline infusion will be given with the same infusion volume as group A and B

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Group C , Normal saline infusion will be given with the same infusion volume as group A and B

midazolam,fentanyl,etomidate,Cisatracurium besylate

Intervention Type DRUG

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

cisatracurium besylate,propofol,remifentanil,sevoflurane

Intervention Type DRUG

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%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

normal saline

Group C , Normal saline infusion will be given with the same infusion volume as group A and B

Intervention Type 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

Intervention Type 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%

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ma Zhengmin

Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ma sedation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine Effect on Delirium of Elderly Patients
NCT06111300 NOT_YET_RECRUITING PHASE4