Back to resultsSmall Doses of Dexmedetomidine for Emergence Agitation
Primary Purpose
Emergence Agitation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Dexmedetomidine
Placebo(for Dexmedetomidine)
Sponsored by
About this trial
This is an interventional treatment trial for Emergence Agitation focused on measuring Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)
Eligibility Criteria
Inclusion Criteria:
- obtain informed consent;
- patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
- the American society of anesthesiologists (ASA) class I-II;
- age>64 years old;
- BMI<28kg/㎡;
Exclusion Criteria:
- systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
- serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
- HR<50times/min
- a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
- a history of alcoholism
- diseases of the neuromuscular
- a tendency to malignant hyperthermia
- allergy to test drugs or have other contraindications
- participated in other clinical drug researches over the past 30 days
Sites / Locations
- Tangdu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevoflurane & Dexmedetomidine
Sevoflurane & Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
evaluation of agitation
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
evaluation of pain
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
the amount of drugs
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
number of agitation
when stay in the hospital, measure the number of agitation.
Secondary Outcome Measures
the mean arterial pressure
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
heart rate
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02169843
Brief Title
Small Doses of Dexmedetomidine for Emergence Agitation
Official Title
Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane & Dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Sevoflurane & Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevoflurome
Intervention Description
inhale Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Hydrochloride Injection
Intervention Description
intravenous pumping Dexmedetomidine 0.2µg/kg/h
Intervention Type
Drug
Intervention Name(s)
Placebo(for Dexmedetomidine)
Other Intervention Name(s)
normal saline
Intervention Description
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
Primary Outcome Measure Information:
Title
evaluation of agitation
Description
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
Time Frame
the duration of PACU room stay,expect 30 minutes
Title
evaluation of pain
Description
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
Time Frame
the duration of PACU room stay,expect 30 minutes
Title
the amount of drugs
Description
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
Time Frame
the duration of hospital stay,expect 5 weeks
Title
number of agitation
Description
when stay in the hospital, measure the number of agitation.
Time Frame
the duration of hospital stay,expect 5 weeks
Secondary Outcome Measure Information:
Title
the mean arterial pressure
Description
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
Time Frame
from the beginning of induction to skin closure, up to 1 hour
Title
heart rate
Description
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
Time Frame
from the beginning of induction to skin closure, up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obtain informed consent;
patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
the American society of anesthesiologists (ASA) class I-II;
age>64 years old;
BMI<28kg/㎡;
Exclusion Criteria:
systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
HR<50times/min
a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
a history of alcoholism
diseases of the neuromuscular
a tendency to malignant hyperthermia
allergy to test drugs or have other contraindications
participated in other clinical drug researches over the past 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meiyan Sun
Phone
15353575016
Email
smyszdlz@126.com
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyan Sun
Phone
15353575016
Email
smyszdlz@126.com
12. IPD Sharing Statement
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Small Doses of Dexmedetomidine for Emergence Agitation
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