Small Doses of Dexmedetomidine for Emergence Agitation

June 19, 2014 updated by: Tang-Du Hospital

Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation

Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(>64 years) after using sevoflurane anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • Tangdu Hospital
        • Contact:

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:

  1. obtain informed consent;
  2. patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
  3. the American society of anesthesiologists (ASA) class I-II;
  4. age>64 years old;
  5. BMI<28kg/㎡;

Exclusion Criteria:

  1. systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
  2. serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
  3. patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
  4. HR<50times/min
  5. a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
  6. a history of alcoholism
  7. diseases of the neuromuscular
  8. a tendency to malignant hyperthermia
  9. allergy to test drugs or have other contraindications
  10. participated in other clinical drug researches over the past 30 days

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane & Dexmedetomidine
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h.
Drug: Sevoflurane
inhale Sevoflurane
Other Names:
  • Sevoflurome
Drug: Dexmedetomidine
intravenous pumping Dexmedetomidine 0.2µg/kg/h
Other Names:
  • Dexmedetomidine Hydrochloride Injection
Active Comparator: Sevoflurane & Placebo
inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h.
Drug: Sevoflurane
inhale Sevoflurane
Other Names:
  • Sevoflurome
Drug: Placebo(for Dexmedetomidine)
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of agitation
Time Frame: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
the duration of PACU room stay,expect 30 minutes
evaluation of pain
Time Frame: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
the duration of PACU room stay,expect 30 minutes
the amount of drugs
Time Frame: the duration of hospital stay,expect 5 weeks
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
the duration of hospital stay,expect 5 weeks
number of agitation
Time Frame: the duration of hospital stay,expect 5 weeks
when stay in the hospital, measure the number of agitation.
the duration of hospital stay,expect 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean arterial pressure
Time Frame: from the beginning of induction to skin closure, up to 1 hour
measure the mean arterial pressure at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes
from the beginning of induction to skin closure, up to 1 hour
heart rate
Time Frame: from the beginning of induction to skin closure, up to 1 hour
measure the heart rate at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes
from the beginning of induction to skin closure, up to 1 hour

Collaborators and Investigators

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

Sponsor

Tang-Du 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

May 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140523 Dexmedetomidine

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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