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Completed

NCT Number: NCT05567523

Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhenjiang First People's Hospital

Zhenjiang, Jiangsu, 212002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: Dex

normal saline

Drug

normal saline

Other names: physiological saline

midazolam

Drug

midazolam

Other names: Dormicum

Primary outcomes

  1. Changes of baseline blood pressure

    Time frame: 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

  2. Changes of baseline heart rate

    Time frame: Through the whole perioperative period, an average of 10 hours

    Changes of baseline heart rate in each group

  3. Numbers of elderly patients with hypotension

    Time frame: 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.

  4. Numbers of elderly patients with bradycardia

    Time frame: 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 outcomes

  1. Sedation changes after general anesthesia using Richmond agitation-sedation scale

    Time frame: 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

  2. Pain changes after general anesthesia using visual analogue scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zhenjiang First People's Hospital

Other

Registry information

Official study title

Effects of Dexmedetomidine at Different Doses on Hemodynamics and Recovery Quality in Elderly Patients Undergoing Hip Replacement Surgery Under General Anesthesia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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