Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

NCT04142840 | Unknown Early Phase 1

• 1 other identifier: DP-TEA Trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Half of participants will receive dexmedetomidine while the other half will receive propofol when emergence agitation happens.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.

  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.

  1 day

Secondary Outcomes (7)

• Riker Sedation-Agitation Scale scores before and after intervention;

  1 day

• Heart rate before and after intervention;

  1 day

• The consumption of sufentanil in the post-anaesthesia care unit;

  1 day

• Nausea and vomiting scores when leaving the post-anesthesia care unit.

  1 day

• Duration in the post-anaesthesia care unit

  1 day

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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

Propofol Group

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine Group

Propofol 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.

Propofol Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital,Shanghai Jiao Tong University,School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34784941 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Song Zhang, MD

CONTACT

15150012530; zhangsong1031@163.com

Weifeng Yu, MD

CONTACT

18918358260; yuweifeng@renji.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 29, 2019
• Study Start: November 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: January 14, 2020

Record last verified: 2019-10

Locations

CN (1)