Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

October 9, 2022 updated by: Zhenjiang First People's Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212002
        • Zhenjiang First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 86 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group D0.25, Group D0.5, Group D0.75
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.
Drug: Dexmedetomidine
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
Placebo Comparator: Group NS, Group MD
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.
Drug: Normal saline
normal saline
Other Names:
  • physiological saline
Drug: Midazolam
midazolam
Other Names:
  • Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through the whole perioperative period, an average of 10 hours
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
Through the whole perioperative period, an average of 10 hours
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.
Through the whole perioperative period, an average of 10 hours
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.
Through the whole perioperative period, an average of 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before general anesthesia, up to 2 hours after general anesthesia
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
before general anesthesia, up to 2 hours after general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhenjiang First People's Hospital

Investigators

  • Study Director: Haitong Liu, Zhenjiang First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 1, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 9, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQK-20190131-W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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