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NCT Number: NCT03262090

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

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

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Key information

Conditions

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

Age range

4 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

0.2ug/kg dexmedetomidine

Drug

subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision

Other names: Age

0.4ug/kg dexmedetomidine

Drug

subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision

Other names: Age

0.6ug/kg dexmedetomidine

Drug

subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision

Other names: Age

0.8ug/kg dexmedetomidine

Drug

subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision

Other names: Age

1.0ug/kg dexmedetomidine

Drug

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

Other names: Age

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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