Clinical trial NCT04142840: Dexmedetomidine and Propofol in the Treatment of Emergence Agitation
Official title: Comparing the Efficacy of Dexmedetomidine and Propofol in the Treatment of Emergence Agitation Occurring in Adults After General Anesthesia: A Randomised Control Trial DP-TEA Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Emergence Agitation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.
timeFrame: 1 day
Secondary outcomes:
measure: Riker Sedation-Agitation Scale scores before and after intervention;
timeFrame: 1 day
measure: Heart rate before and after intervention;
timeFrame: 1 day
measure: The consumption of sufentanil in the post-anaesthesia care unit;
timeFrame: 1 day
measure: Nausea and vomiting scores when leaving the post-anesthesia care unit.
timeFrame: 1 day
measure: Duration in the post-anaesthesia care unit
timeFrame: 1 day
measure: Recovering quality: recovery scale
timeFrame: 24 hours after surgery.
measure: Mean blood pressure before and after intervention;
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital,Shanghai Jiao Tong University,School of Medicine
state: Shanghai
Study officials:
References:
citation: Feng Z, Shi X, Yan X, Zhu Y, Gu J, Zhu H, Yu W, Zhang S. Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial). Trials. 2021 Nov 16;22(1):811. doi: 10.1186/s13063-021-05743-2.