Small Doses of Dexmedetomidine for Emergence Agitation

Tang-Du Hospital

Status and phase: Unknown; Phase 4

Conditions: Emergence Agitation

Treatments: Drug: Sevoflurane; Drug: Placebo(for Dexmedetomidine); Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02169843

20140523 Dexmedetomidine

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Sevoflurane & Dexmedetomidine

Experimental group

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.

Treatment:

Drug: Dexmedetomidine

Drug: Sevoflurane

Sevoflurane & Placebo

Active Comparator group

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.

Treatment:

Drug: Placebo(for Dexmedetomidine)

Drug: Sevoflurane