A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

October 13, 2016 updated by: So Yeon Kim, Severance Hospital
The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged ≥ 65 years
  • ASA physical status class I-II
  • the patients who want sedation during elective lower limb surgery under spinal anesthesia

Exclusion Criteria:

  • contraindication to spinal anesthesia
  • neurologic or cognitive dysfunction
  • severe cardiovascular or pulmonary disease
  • refusal to participation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine alone
dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion
Drug: dexmedetomidine alone or dexmedetomidine + midazolam
Experimental: dexmedetomidine + midazolam
normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion
Drug: dexmedetomidine alone or dexmedetomidine + midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic stability
Time Frame: 4 hour
comparison of bradycardia incidence
4 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Observer Assessment of Alertness/Sedation (MOAAS) scale
Time Frame: 4 hour
4 hour

Collaborators and Investigators

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

Sponsor

Severance Hospital

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

November 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 3, 2013

First Submitted That Met QC Criteria

November 3, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0615

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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