Small Doses of Dexmedetomidine for Emergence Agitation

NCT02169843 | Unknown Phase 4

• 1 other identifier: 20140523 Dexmedetomidine
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Keywords

Dexmedetomidine,; agitation,; AFPS,; NRS,; mean arterial pressure; heart rate(HR)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• the mean arterial pressure

  from the beginning of induction to skin closure, up to 1 hour

• heart rate

  from the beginning of induction to skin closure, up to 1 hour

Study Arms (2)

Sevoflurane & Dexmedetomidine

EXPERIMENTAL

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; Drug: Dexmedetomidine

Sevoflurane & Placebo

ACTIVE COMPARATOR

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; Drug: Placebo(for Dexmedetomidine)

Interventions

Sevoflurane DRUG

inhale Sevoflurane

Also known as: Sevoflurome

Sevoflurane & Dexmedetomidine; Sevoflurane & Placebo

Dexmedetomidine DRUG

intravenous pumping Dexmedetomidine 0.2µg/kg/h

Also known as: Dexmedetomidine Hydrochloride Injection

Sevoflurane & Dexmedetomidine

Placebo(for Dexmedetomidine) DRUG

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

Also known as: normal saline

Sevoflurane & Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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/㎡;

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Psychomotor Agitation

Interventions

Sevoflurane; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Meiyan Sun

CONTACT

15353575016; smyszdlz@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 23, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

CN (1)