Emergence Agitation
Conditions
Keywords
Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)
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.
Interventions
DRUGSevoflurane
inhale Sevoflurane
DRUGDexmedetomidine
intravenous pumping Dexmedetomidine 0.2µg/kg/h
DRUGPlacebo(for Dexmedetomidine)
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of agitation | 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. |
| evaluation of pain | 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 amount of drugs | the duration of hospital stay,expect 5 weeks | when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using |
| number of agitation | the duration of hospital stay,expect 5 weeks | when stay in the hospital, measure the number of agitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the mean arterial pressure | 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 |
| heart rate | 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 |
Countries
China
Contacts
Primary ContactMeiyan Sun
Outcome results
None listed