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Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

Primary Purpose

Hip Fractures, Hip Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Midazolam
Sponsored by
Zhenjiang First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring Dexmedetomidine, Elderly, Hemodynamics, Hip replacement, General anesthesia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhenjiang First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Group NS, Group MD

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes of baseline blood pressure
Changes of baseline blood pressure in each group, including systolic blood pressure, diastolic blood pressure and mean arterial pressure
Changes of baseline heart rate
Changes of baseline heart rate in each group
Numbers of elderly patients with hypotension
Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure below >20% of basal values.
Numbers of elderly patients with bradycardia
Bradycardia is defined as heart rate <50 beats/min or below >20% of basal values.

Secondary Outcome Measures

Sedation changes after general anesthesia using Richmond agitation-sedation scale
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
Pain changes after general anesthesia using visual analogue scale(0 to 10,higher scores mean a worse outcome) in each group

Full Information

First Posted
September 29, 2022
Last Updated
October 9, 2022
Sponsor
Zhenjiang First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05567523
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhenjiang First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Hip Disease
Keywords
Dexmedetomidine, Elderly, Hemodynamics, Hip replacement, General anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D0.25, Group D0.5, Group D0.75
Arm Type
Experimental
Arm 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.
Arm Title
Group NS, Group MD
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
physiological saline
Intervention Description
normal saline
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
midazolam
Primary Outcome Measure Information:
Title
Changes of baseline blood pressure
Description
Changes of baseline blood pressure in each group, including systolic blood pressure, diastolic blood pressure and mean arterial pressure
Time Frame
Through the whole perioperative period, an average of 10 hours
Title
Changes of baseline heart rate
Description
Changes of baseline heart rate in each group
Time Frame
Through the whole perioperative period, an average of 10 hours
Title
Numbers of elderly patients with hypotension
Description
Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure below >20% of basal values.
Time Frame
Through the whole perioperative period, an average of 10 hours
Title
Numbers of elderly patients with bradycardia
Description
Bradycardia is defined as heart rate <50 beats/min or below >20% of basal values.
Time Frame
Through the whole perioperative period, an average of 10 hours
Secondary Outcome Measure Information:
Title
Sedation changes after general anesthesia using Richmond agitation-sedation scale
Description
Sedation changes after general anesthesia using Richmond agitation-sedation scale(-5 to +4, 0 means awake and quiet) in each group
Time Frame
before general anesthesia, up to 2 hours after general anesthesia
Title
Pain changes after general anesthesia using visual analogue scale
Description
Pain changes after general anesthesia using visual analogue scale(0 to 10,higher scores mean a worse outcome) in each group
Time Frame
before general anesthesia, up to 2 hours after general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitong Liu
Organizational Affiliation
Zhenjiang First People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhenjiang First People's Hospital
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
Data are available after publication and up to one year after publication.
IPD Sharing Access Criteria
Send an email to dolinet@163.com
Citations:
PubMed Identifier
28854538
Citation
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Results Reference
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28854543
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.
Results Reference
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Citation
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Citation
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Citation
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Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

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