Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

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

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.

Study Overview

• Status: Unknown
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Renji Hospital,Shanghai Jiao Tong University,School of Medicine
      • Contact: Song Zhang, MD; Phone Number: 86+15150012530; Email: zhangsong1031@163.com
      • Contact: Weifeng Yu, MD; Phone Number: 86+18918358260; Email: yuweifeng@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dexmedetomidine; a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.	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.; A Riker Sedation-Agitation scale score of 5 or more than 5 will be considered as emergence agitation.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Riker Sedation-Agitation Scale scores before and after intervention;	Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome.	1 day
Heart rate before and after intervention;	Heart rate wil be recorded in beats per minute.	1 day
The consumption of sufentanil in the post-anaesthesia care unit;	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.	1 day
Nausea and vomiting scores when leaving the post-anesthesia care unit.	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.	1 day
Duration in the post-anaesthesia care unit	The total time from entering the post-anaesthesia care unit to leaving the post-anaesthesia care unit.	1 day
Recovering quality: recovery scale	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.	24 hours after surgery.
Mean blood pressure before and after intervention;	Mean blood pressure will be recorded in millimeters of mercury.	1 day

Collaborators and Investigators

• Sponsor: RenJi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 11, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: DP-TEA Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No