Dexmedetomidine and Propofol in the Treatment of 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

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-08-30

Brief Summary

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1. This clinical research aims to compare the effects of dexmedetomidine and propofol on the treatment of emergence agitation in adult patients after general anesthesia.
2. Half of participants will receive dexmedetomidine while the other half will receive propofol when emergence agitation happens.

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Detailed Description

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As a common problem observed in pediatric patients after sevoflurane anesthesia, emergence agitations are investigated mainly in children.For adults,previous studies were almost about the efficacy of premedication on preventing emergence agitation. Once emergence agitation happens, there is still no guidelines established to recommend the medication usage in the post-anaesthesia care unit.So high-quality prospective clinical studies are required to provide evidence for emergence agitation treatment.

Dexmedetomidine and propofol are both widely used in general anesthesia and can be acquired easily.When emergence agitation occurs,both injections are common choices in daily clinical administration on emergence agitation.To the investigator's knowledge ,propofol with a very quick onset is superior for anesthesia goals, but is without analgesia effects.While dexmedetomidine can produce sedation,analgesia,anxiolysis.So the investigators propose the hypothesis here that dexmedetomidine is prior to propofol on the treatment of emergence agitation in adults patients after general anesthesia.Therefore this research is undertaken to verify the hypothesis.

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexmedetomidine Group

General anesthesia will be maintained by sevoflurane and remifentanil. End-tidal carbon dioxide will be controlled between 35 mmHg to 40 mmHg.Mean blood pressure(MAP) will be administrated between 80% and 120% of the baseline.Heart rate is going to be maintained between 50-100 beats per minute.

In consultation with the surgeons and 5 minutes prior to the departure of the operating room,all the anesthesia agents are discontinued and the patient will be transferred to the post-anaesthesia care unit.And reversal agents are given to antagonize the residual muscular relaxant.Once emergence agitation occurs,the patient assigned to the dexmedetomidine group will be infused with a single dose of 0.7ug/kg dexmedetomidine.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia

Propofol Group

General anesthesia will be maintained by sevoflurane and remifentanil. End-tidal carbon dioxide will be controlled between 35 mmHg to 40 mmHg.Mean blood pressure(MAP) will be administrated between 80% and 120% of the baseline.Heart rate is going to be maintained between 50-100 beats per minute.

In consultation with the surgeons and 5 minutes prior to the departure of the operating room,all the anesthesia agents are discontinued and the patient will be transferred to the post-anaesthesia care unit.And reversal agents are given to antagonize the residual muscular relaxant.Once emergence agitation occurs,the patient assigned to the propofol group will be infused with a single dose of 0.5mg/kg propofol.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

a short -acting medication that result in a decreased level of consciousness and lack of memory for events,widely used including the starting and maintenance of general anesthesia.

Interventions

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Dexmedetomidine

a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia

Intervention Type DRUG

Propofol

a short -acting medication that result in a decreased level of consciousness and lack of memory for events,widely used including the starting and maintenance of general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18-65 years old after general anesthesia
* with informed consent provided.

Exclusion Criteria

* age younger than 18 years or older than 65 years;
* American Society of Anesthesiologists classification ≥Ⅲ;
* preoperative lung dysfunction(including pneumonia,atelectasis,adult respiratory distress syndrome,acute lung injury and so on);
* preoperative heart dysfunction(including sever cardiac coronary disease,unstable angina,LVEF≤30％，sick sinus syndrome，bradycardia:heart rate≤50bpm,second or third degree A-V block);
* history of mental disease;
* no informed consent provided;
* uncontrolled hypertension(baseline blood pressure:SBP≥160mmHg or DBP≥110mmHg);
* cancers;
* enrolled in other researches within 90 days;
* allergic to intervening medicine.
* BMI less than 18 or more than 30 kg/m2.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes