Ambulatory Surgical ProceduresNCT03262090
Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
A study testing 0.2ug/kg dexmedetomidine, 0.4ug/kg dexmedetomidine and 0.6ug/kg dexmedetomidine in people with Ambulatory Surgical Procedures, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 months to 15 years
- Conditions the study is for
- Ambulatory Surgical Procedures
- What is being tested?
- 0.2ug/kg dexmedetomidine, 0.4ug/kg dexmedetomidine and 0.6ug/kg dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2017to 21 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000
About this study
Official title: 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
Read the 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.
- Conditions
- Ambulatory Surgical Procedures
- Being tested
- 0.2ug/kg dexmedetomidine, 0.4ug/kg dexmedetomidine, 0.6ug/kg dexmedetomidine, 0.8ug/kg dexmedetomidine, 1.0ug/kg dexmedetomidine
- Keywords
- Emergence Delirium, desoflurane, general anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2ug/kg dexmedetomidineDrug
Also called Age
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
0.4ug/kg dexmedetomidineDrug
Also called Age
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
0.6ug/kg dexmedetomidineDrug
Also called Age
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
0.8ug/kg dexmedetomidineDrug
Also called Age
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
1.0ug/kg dexmedetomidineDrug
Also called Age
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Subjects were randomly assigned to receive saline before skin incision |
| 0.2ug/kg dexmedetomidine | Active comparator | Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision Receives: Drug: 0.2ug/kg dexmedetomidine |
| 0.4ug/kg dexmedetomidine | Active comparator | Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision Receives: Drug: 0.4ug/kg dexmedetomidine |
| 0.6ug/kg dexmedetomidine | Active comparator | Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision Receives: Drug: 0.6ug/kg dexmedetomidine |
| 0.8ug/kg dexmedetomidine | Active comparator | Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision Receives: Drug: 0.8ug/kg dexmedetomidine |
| 1.0ug/kg dexmedetomidine | Active comparator | Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision Receives: Drug: 1.0ug/kg dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of emergence agitation at different time interval after emergence
emergence agitation was evaluated by five-point scale
Measured: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary outcomes (3)
sedation scales at different time interval after emergence
sedation was evaluated by MOAA/S scores
Measured: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
pain scale at different time interval after emergence
pain scale was evaluated by FLACC
Measured: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
incidence of emergence delirium at different time interval after emergence
emergence delirium was evaluated by five-point scale
Measured: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start18 Sep 2017
- Primary completion15 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jun She, MD, Guangzhou Women and Children's Medical Center
- Investigators
- Xia Zheng, Doctor, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262090
- Sponsor's protocol ID
- YShe
- Status last verified
- Jun 2019
- First submitted
- 18 Aug 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT03262090
- Acronym / sponsor ID
- YShe
- Conditions
- Ambulatory Surgical Procedures
- Keywords
- Emergence Delirium, desoflurane, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Subjects were randomly assigned to receive saline before skin incision |
| 0.2ug/kg dexmedetomidine | Active comparator | Drug: 0.2ug/kg dexmedetomidineSubjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision |
| 0.4ug/kg dexmedetomidine | Active comparator | Drug: 0.4ug/kg dexmedetomidineSubjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision |
| 0.6ug/kg dexmedetomidine | Active comparator | Drug: 0.6ug/kg dexmedetomidineSubjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision |
| 0.8ug/kg dexmedetomidine | Active comparator | Drug: 0.8ug/kg dexmedetomidineSubjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision |
| 1.0ug/kg dexmedetomidine | Active comparator | Drug: 1.0ug/kg dexmedetomidineSubjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision |
Who may qualify
- Ages
- 4 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.2ug/kg dexmedetomidineAlso: Agesubjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision | Drug | 0.2ug/kg dexmedetomidine |
| 0.4ug/kg dexmedetomidineAlso: Agesubjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision | Drug | 0.4ug/kg dexmedetomidine |
| 0.6ug/kg dexmedetomidineAlso: Agesubjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision | Drug | 0.6ug/kg dexmedetomidine |
| 0.8ug/kg dexmedetomidineAlso: Agesubjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision | Drug | 0.8ug/kg dexmedetomidine |
| 1.0ug/kg dexmedetomidineAlso: Agesubjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision | Drug | 1.0ug/kg dexmedetomidine |
Primary outcome
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
3 secondary outcomes
sedation scales at different time interval after emergence
Time frame: 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
incidence of emergence delirium at different time interval after emergence
Time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Zheng, Doctor principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.2ug/kg dexmedetomidine, 0.4ug/kg dexmedetomidine and 0.6ug/kg dexmedetomidine in people with Ambulatory Surgical Procedures, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of emergence agitation at different time interval after emergence (time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.