Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

Early Phase 1

• Conditions: Emergence Agitation
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT04142840
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-19
• Study First Submitted QC: 2019-10-26
• Study First Posted: 2019-10-29
• Study Start: 2019-11-01
• Last Update Submitted: 2020-01-11
• Last Update Posted: 2020-01-14
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Group	Dexmedetomidine	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.
Propofol Group	Propofol	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.

Primary Outcome Measures

Name	Time	Method
The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.	1 day	1. The Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome.; 2. A Riker Sedation-Agitation scale score of 5 or more than 5 will be considered as emergence agitation.

Secondary Outcome Measures

Name	Time	Method
Riker Sedation-Agitation Scale scores before and after intervention;	1 day	Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome.
Heart rate before and after intervention;	1 day	Heart rate wil be recorded in beats per minute.
The consumption of sufentanil in the post-anaesthesia care unit;	1 day	During the procedure,a dose of 0.01ug/kg sulfentanil will be given when numeric rating scale scores≥ 5 scores or the patient has a analgesia request; Numeric rating scale,with a maximum value of 10 and a minimum value of 0,is specifically as follows:0-3,slight pain;4-7,moderate pain;8-10,sever pain.Lower scores mean a better outcome.
Nausea and vomiting scores when leaving the post-anesthesia care unit.	1 day	According the following scale with a maximum value of 3 and a minimum value of 0,is specifically as follows:0,no nausea;1,mild nausea;2,sever nausea requiring antiemetics;3,retching,vomiting or both.Lower scores mean a better outcome.
Duration in the post-anaesthesia care unit	1 day	The total time from entering the post-anaesthesia care unit to leaving the post-anaesthesia care unit.
Recovering quality: recovery scale	24 hours after surgery.	The recovering quality is evaluated by the 40-item quality of recovery scale,with a maximum value of 200 and a minimum value of 0.Higher scores mean a better outcome.
Mean blood pressure before and after intervention;	1 day	Mean blood pressure will be recorded in millimeters of mercury.

Trial Locations

Locations (1)

Renji Hospital,Shanghai Jiao Tong University,School of Medicine; 🇨🇳 Shanghai, Shanghai, China