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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Cognitive Dysfunction

Treatments: Drug: dexmedetomidine; Drug: normal saline; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02224443

Ma sedation

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Group A, dexmedetomidine , 0.3µg.kg-1.h-1

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine

Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate

Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Drug: dexmedetomidine

Group B,dexmedetomidine , 0.5µg.kg-1.h-1

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine

Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate

Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Drug: dexmedetomidine

Group C ,normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate

Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Drug: normal saline