Small Doses of Dexmedetomidine for Emergence Agitation

Study Overview
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Brief Summary
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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.

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

Conditions
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Emergence Agitation

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Dexmedetomidine
* Drug: Placebo(for Dexmedetomidine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane & Dexmedetomidine<br>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<br>* inhale Sevoflurane<br>* Other names: Sevoflurome;Drug: Dexmedetomidine<br>* intravenous pumping Dexmedetomidine 0.2µg/kg/h<br>* Other names: Dexmedetomidine Hydrochloride Injection;|
| Active Comparator: Sevoflurane & Placebo<br>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<br>* inhale Sevoflurane<br>* Other names: Sevoflurome;Drug: Placebo(for Dexmedetomidine)<br>* normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of agitation | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)