Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Small Doses of Dexmedetomidine for Emergence Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169843
Recruitment Status : Unknown
Verified June 2014 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Emergence Agitation Drug: Sevoflurane Drug: Dexmedetomidine Drug: Placebo(for Dexmedetomidine) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
Study Start Date : May 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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 Name: Sevoflurome

Drug: Dexmedetomidine
intravenous pumping Dexmedetomidine 0.2µg/kg/h
Other Name: 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 Name: Sevoflurome

Drug: Placebo(for Dexmedetomidine)
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
Other Name: normal saline




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. number of agitation [ Time Frame: the duration of hospital stay,expect 5 weeks ]
    when stay in the hospital, measure the number of agitation.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169843


Contacts
Layout table for location contacts
Contact: Meiyan Sun 15353575016 smyszdlz@126.com

Locations
Layout table for location information
China, Shanxi
Tangdu Hospital Recruiting
Xi'an, Shanxi, China
Contact: Meiyan Sun    15353575016    smyszdlz@126.com   
Sponsors and Collaborators
Tang-Du Hospital

Layout table for additonal information
Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02169843    
Other Study ID Numbers: 20140523 Dexmedetomidine
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Tang-Du Hospital:
Dexmedetomidine,
agitation,
AFPS,
NRS,
mean arterial pressure
heart rate(HR)
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors