Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery

June 24, 2019 updated by: Ying Jun She, MD, Guangzhou Women and Children's Medical Center

Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia

Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. In infants, there is a high incidence of emergence agitation (EA) after desoflurane anesthesia. The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years group, and 3-12 years group. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Women and Children Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery
  2. Patients who are American Society of Anesthesiologists classification I and II
  3. Patients who are 4 months through 15 years of age

Exclusion Criteria:

1. children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities.

3. patients with any congenital malformation or acquired disease that could increase the risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital heart disease, hydronephrosis, nutrition dysplasia). 4. patients with long-term use of sedative or analgesic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Subjects were randomly assigned to receive saline before skin incision
Active Comparator: 0.2ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
Drug: 0.2ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
Other Names:
  • Age
Active Comparator: 0.4ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
Drug: 0.4ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
Other Names:
  • Age
Active Comparator: 0.6ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
Drug: 0.6ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
Other Names:
  • Age
Active Comparator: 0.8ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
Drug: 0.8ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
Other Names:
  • Age
Active Comparator: 1.0ug/kg dexmedetomidine
Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Drug: 1.0ug/kg dexmedetomidine
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Other Names:
  • Age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of emergence agitation at different time interval after emergence
Time Frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
emergence agitation was evaluated by five-point scale
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation scales at different time interval after emergence
Time Frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
sedation was evaluated by MOAA/S scores
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
pain scale at different time interval after emergence
Time Frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
pain scale was evaluated by FLACC
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
incidence of emergence delirium at different time interval after emergence
Time Frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
emergence delirium was evaluated by five-point scale
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Investigators

  • Principal Investigator: Xia Zheng, Doctor, Guangzhou Women and Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 21, 2019

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YShe

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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