Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

Zhenjiang First People's Hospital

Status and phase: Completed; Phase 4

Conditions: Hip Fractures; Hip Disease

Treatments: Drug: Normal saline; Drug: Dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05567523

SQK-20190131-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Group D0.25, Group D0.5, Group D0.75

Experimental group

Description:

Dexmedetomidine will be administered at different initial loading doses (0.25/0.5/0.75 μg/kg within 15min) following same maintained dosage ( 0.5μg/kg/h) in Group D0.25/D0.5/D0.75.

Treatment:

Drug: Dexmedetomidine

Group NS, Group MD

Placebo Comparator group

Description:

In Group NS, patients will be pumped 0.1ml/kg of normal saline for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation. In Group MD, patients will be administrated with midazolam 0.03mg/kg at the beginning of anesthesia induction.

Treatment:

Drug: Midazolam

Drug: Normal saline