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Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

Primary Purpose

Emergence Agitation

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergence Agitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Renji Hospital,Shanghai Jiao Tong University,School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine Group

Propofol Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Heart rate before and after intervention;
Heart rate wil be recorded in beats per minute.
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.
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.
Duration in the post-anaesthesia care unit
The total time from entering the post-anaesthesia care unit to leaving the post-anaesthesia care unit.
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.
Mean blood pressure before and after intervention;
Mean blood pressure will be recorded in millimeters of mercury.

Full Information

First Posted
October 19, 2019
Last Updated
January 11, 2020
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04142840
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This clinical research aims to compare the effects of dexmedetomidine and propofol on the treatment of emergence agitation in adult patients after general anesthesia. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine Group
Arm Type
Experimental
Arm 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.
Arm Title
Propofol Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The recurrence rate of emergence agitation assessed by the Riker Sedation-Agitation Scale after the treatment of each group.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Riker Sedation-Agitation Scale scores before and after intervention;
Description
Riker Sedation-Agitation Scale is raging from a maximum value of 7 to a minimum value of 1.Lower scores mean a better outcome.
Time Frame
1 day
Title
Heart rate before and after intervention;
Description
Heart rate wil be recorded in beats per minute.
Time Frame
1 day
Title
The consumption of sufentanil in the post-anaesthesia care unit;
Description
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.
Time Frame
1 day
Title
Nausea and vomiting scores when leaving the post-anesthesia care unit.
Description
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.
Time Frame
1 day
Title
Duration in the post-anaesthesia care unit
Description
The total time from entering the post-anaesthesia care unit to leaving the post-anaesthesia care unit.
Time Frame
1 day
Title
Recovering quality: recovery scale
Description
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.
Time Frame
24 hours after surgery.
Title
Mean blood pressure before and after intervention;
Description
Mean blood pressure will be recorded in millimeters of mercury.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Zhang, MD
Phone
15150012530
Email
zhangsong1031@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Yu, MD
Phone
18918358260
Email
yuweifeng@renji.com
Facility Information:
Facility Name
Renji Hospital,Shanghai Jiao Tong University,School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Zhang, MD
Phone
86+15150012530
Email
zhangsong1031@163.com
First Name & Middle Initial & Last Name & Degree
Weifeng Yu, MD
Phone
86+18918358260
Email
yuweifeng@renji.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34784941
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.
Results Reference
derived

Learn more about this trial

Dexmedetomidine and Propofol in the Treatment of Emergence Agitation

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