Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

Shanghai Jiao Tong University

Status and phase: Unknown; Early Phase 1

Conditions: Emergence Agitation

Treatments: Drug: Dexmedetomidine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04142840

DP-TEA Trial

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Propofol Group

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol