Small Doses of Dexmedetomidine for Emergence Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

inhale Sevoflurane

Dexmedetomidine

Intervention Type DRUG

intravenous pumping Dexmedetomidine 0.2µg/kg/h

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.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

inhale Sevoflurane

Placebo(for Dexmedetomidine)

Intervention Type DRUG

normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h

Interventions

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Sevoflurane

inhale Sevoflurane

Intervention Type DRUG

Dexmedetomidine

intravenous pumping Dexmedetomidine 0.2µg/kg/h

Intervention Type DRUG

Placebo(for Dexmedetomidine)

normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h

Intervention Type DRUG

Other Intervention Names

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Sevoflurome Dexmedetomidine Hydrochloride Injection normal saline

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No