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

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03262090
Collaborator
(none)
389
Enrollment
1
Location
6
Arms
20
Actual Duration (Months)
19.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.2ug/kg dexmedetomidine
  • Drug: 0.4ug/kg dexmedetomidine
  • Drug: 0.6ug/kg dexmedetomidine
  • Drug: 0.8ug/kg dexmedetomidine
  • Drug: 1.0ug/kg dexmedetomidine
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
389 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. 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.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. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. 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.
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
Actual Study Start Date :
Sep 18, 2017
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 21, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence of emergence agitation at different time interval after emergence [at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence]

      emergence agitation was evaluated by five-point scale

    Secondary Outcome Measures

    1. sedation scales at different time interval after emergence [at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence]

      sedation was evaluated by MOAA/S scores

    2. pain scale at different time interval after emergence [at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence]

      pain scale was evaluated by FLACC

    3. incidence of emergence delirium at different time interval after emergence [at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence]

      emergence delirium was evaluated by five-point scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Months to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Women and Children Medical Center Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Guangzhou Women and Children's Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ying Jun She, MD, Dr., Guangzhou Women and Children's Medical Center
    ClinicalTrials.gov Identifier:
    NCT03262090
    Other Study ID Numbers:
    • YShe
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Jun 25, 2019
    Last Verified:
    Jun 1, 2019
    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
    Keywords provided by Ying Jun She, MD, Dr., Guangzhou Women and Children's Medical Center
    Emergence Delirium
    desoflurane
    general anesthesia
    Additional relevant MeSH terms:
    Emergence Delirium
    Dexmedetomidine

    Study Results

    No Results Posted as of Jun 25, 2019