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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2019-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

NCT01691001

Ambulation Difficulty

COMPLETED NA

Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children

NCT03596775

Emergence Agitation

UNKNOWN EARLY_PHASE1

The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

NCT01578161

Psychomotor Agitation

UNKNOWN PHASE4

Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

NCT05813106

Emergence Delirium Dexmeditomidine

UNKNOWN PHASE4

Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children

NCT03171740

Emergence Delirium

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ambulatory Surgical Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Subjects were randomly assigned to receive saline before skin incision

Intervention Type DRUG

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

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Age Age Age Age Age

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

4 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No