Hip Disease, Hip Fractures
Conditions
Keywords
Dexmedetomidine, Elderly, Hemodynamics, Hip replacement, General anesthesia
Brief 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.
Detailed description
All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, the patients will be randomized into different doses of dexmedetomidine groups and the comparative groups in a same ratio.
Interventions
DRUGDexmedetomidine
In dexmedetomidine groups, patients will be pumped 0.1ml/kg of dexmedetomidine (contained dexmedetomidine 0.25/0.5/0.75µg/kg in Group D0.25/D0.5/D0.75) for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation.
DRUGNormal saline
normal saline
DRUGMidazolam
midazolam
Sponsors
Zhenjiang First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of baseline blood pressure | Through the whole perioperative period, an average of 10 hours | Changes of baseline blood pressure in each group, including systolic blood pressure, diastolic blood pressure and mean arterial pressure |
| Changes of baseline heart rate | Through the whole perioperative period, an average of 10 hours | Changes of baseline heart rate in each group |
| Numbers of elderly patients with hypotension | Through the whole perioperative period, an average of 10 hours | Hypotension is defined as systolic blood pressure \<90 mmHg or mean arterial pressure below \>20% of basal values. |
| Numbers of elderly patients with bradycardia | Through the whole perioperative period, an average of 10 hours | Bradycardia is defined as heart rate \<50 beats/min or below \>20% of basal values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation changes after general anesthesia using Richmond agitation-sedation scale | before general anesthesia, up to 2 hours after general anesthesia | Sedation changes after general anesthesia using Richmond agitation-sedation scale(-5 to +4, 0 means awake and quiet) in each group |
| Pain changes after general anesthesia using visual analogue scale | before general anesthesia, up to 2 hours after general anesthesia | Pain changes after general anesthesia using visual analogue scale(0 to 10,higher scores mean a worse outcome) in each group |
Countries
China
Outcome results
None listed