Small Doses of Dexmedetomidine for Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02169843
• Other study ID #: 20140523 Dexmedetomidine
• Status: Recruiting
• Phase: Phase 4
• First received: May 26, 2014
• Last updated: June 19, 2014
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: June 2014
• Source: Tang-Du Hospital
• Contact: Meiyan Sun
• Phone: 15353575016
• Email: smyszdlz[@]126.com
• Is FDA regulated: No
• Health authority: China: National Institutes for Food and Drug Contorl
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergence Agitation
• Psychomotor Agitation

Intervention

Drug:
• Sevoflurane
inhale Sevoflurane
• Dexmedetomidine
intravenous pumping Dexmedetomidine 0.2µg/kg/h
• Placebo(for Dexmedetomidine)
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	number of agitation	when stay in the hospital, measure the number of agitation.	the duration of hospital stay,expect 5 weeks	No
Secondary	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	No
Secondary	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	No