Small Doses of Dexmedetomidine for Emergence Agitation

Phase 4

• Conditions: Emergence Agitation
• Interventions: Drug: Sevoflurane; Drug: Placebo(for Dexmedetomidine); Drug: Dexmedetomidine

• Registration Number: NCT02169843
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-26
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-19
• Last Update Submitted: 2014-06-19
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane & Placebo	Placebo(for 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 Placebo(for Dexmedetomidine )0.05ml/kg/h.
Sevoflurane & Dexmedetomidine	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.
Sevoflurane & Dexmedetomidine	Sevoflurane	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.
Sevoflurane & Placebo	Sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
evaluation of agitation	the duration of PACU room stay,expect 30 minutes	stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
the amount of drugs	the duration of hospital stay,expect 5 weeks	when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
number of agitation	the duration of hospital stay,expect 5 weeks	when stay in the hospital, measure the number of agitation.
evaluation of pain	the duration of PACU room stay,expect 30 minutes	stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.

Secondary Outcome Measures

Name	Time	Method
the mean arterial pressure	from the beginning of induction to skin closure, up to 1 hour	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
heart rate	from the beginning of induction to skin closure, up to 1 hour	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

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shanxi, China