Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

• Status: Completed
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide the elderly patients satisfactory sedation and analgesia with stable hemodynamics during perioperative period of hip replacement under general anesthesia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhenjiang First People's Hospital
• Treatments: Dexmedetomidine; Midazolam

Criteria

Inclusion Criteria:

• age ≥65yr, American Society of Anesthesiologists (ASA) physical status scale grade I-III, ready for HP; body weight between 45 and 75kg, body mass index (BMI) between 18 and 24kg/m2;

• the health conditions generally well according to medical history, physical examination, and laboratory tests;

• no signs of difficult intubation;

• no history of dementia and mental problems;

• normal cognitive function, ability to understand and comply with study procedures.

Exclusion Criteria:

• Age <65 yr or >90 yr; BMI greater than 24 kg/m2; ASA grade higher than III;

• Heart failure, severe arrhythmias, severe bradycardia (heart rate less than 40 beats/min), atrioventricular block of degree 2 or above, sick sinus syndrome, systolic blood pressure (SBP) ≥180 or <90 mmHg, diastolic blood pressure (DBP) ≥110 or <60 mmHg;

• Severe liver or kidney dysfunction, severe infection, and other pathological conditions that interfere with study results.

• Dementia, cerebrovascular accidents within 3 months, mental illness, epilepsy, and other adverse events that interfere with study results.

• Patients with the conditions that block communication and preoperative assessment, such as serious hearing or visual impairment;

• History of chronic analgesic use, long-term psychotropic medication use, alcohol or drug addiction.