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

NCT03262090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2019-06-25

No results posted yet for this study

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

Conditions

  • Ambulatory Surgical Procedures

Interventions

DRUG

0.2ug/kg dexmedetomidine

subjects were randomly assigned to receive 0.2ug/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

DRUG

0.6ug/kg dexmedetomidine

subjects were randomly assigned to receive 0.6ug/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

DRUG

1.0ug/kg dexmedetomidine

subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Principal Investigators

  • Xia Zheng, Doctor · Guangzhou Women and Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2019-05-15
Completion
2019-05-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262090 on ClinicalTrials.gov