Clinical trial NCT05567523: Safety Study of Dexmedetomidine in Elderly Under General Anesthesia
Official title: Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Hip Disease
Keywords: Dexmedetomidine
Elderly
Hemodynamics
Hip replacement
General anesthesia
Lead sponsor: Zhenjiang First People's Hospital
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Changes of baseline blood pressure
timeFrame: Through the whole perioperative period, an average of 10 hours
measure: Changes of baseline heart rate
timeFrame: Through the whole perioperative period, an average of 10 hours
measure: Numbers of elderly patients with hypotension
timeFrame: Through the whole perioperative period, an average of 10 hours
measure: Numbers of elderly patients with bradycardia
timeFrame: Through the whole perioperative period, an average of 10 hours
Secondary outcomes:
measure: Sedation changes after general anesthesia using Richmond agitation-sedation scale
timeFrame: before general anesthesia, up to 2 hours after general anesthesia
measure: Pain changes after general anesthesia using visual analogue scale
timeFrame: before general anesthesia, up to 2 hours after general anesthesia
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
state: Jiangsu
Study officials:
affiliation: Zhenjiang First People's Hospital
name: Haitong Liu
role: STUDY_DIRECTOR
References:
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citation: Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacodynamics in healthy volunteers: 2. Haemodynamic profile. Br J Anaesth. 2017 Aug 1;119(2):211-220. doi: 10.1093/bja/aex086.
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