Inhalational Anesthetics Adverse ReactionPhase 4NCT01895023
Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
A Phase 4 study testing Dexmedetomidine, Midazolam and Saline in people with Inhalational Anesthetics Adverse Reaction and Delirium on Emergence, run by Yao Yusheng at 1 site in China.
Trial summary
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery
- What is being tested?
- Dexmedetomidine, Midazolam and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 4
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia
Who cannot join
- mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families.
Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.
Read the detailed description
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.
A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.
- Conditions
- Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery
- Being tested
- Dexmedetomidine, Midazolam, Saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called alpha2-adrenoceptor agonist
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
MidazolamDrug
Also called GABA modulators
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
SalineDrug
Also called sodium chloride injection (0.9%Nacl)
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia Receives: Drug: Dexmedetomidine |
| Midazolam group | Active comparator | The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia. Receives: Drug: Midazolam |
| Placebo Group | Placebo comparator | The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.
A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.
Measured: participants will be followed for the duration of PACU stay, an expected average of 1 hour
Secondary outcomes (1)
Postoperative vomiting
Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inhalational Anesthetics Adverse ReactionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yao Yusheng
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Yusheng Yao, M.D., Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895023
- Sponsor's protocol ID
- FujianPH-TRC-130615
- Status last verified
- Jan 2015
- First submitted
- 28 Jun 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.
PubMed 32976205
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
- ClinicalTrials.gov ID
- NCT01895023
- Acronym / sponsor ID
- FujianPH-TRC-130615
- Conditions
- Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Yao YushengUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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.
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families.
Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.
Detailed description
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.
A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineThe dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia |
| Midazolam group | Active comparator | Drug: MidazolamThe midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia. |
| Placebo Group | Placebo comparator | Drug: SalineThe Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia
Key exclusion criteria (1 listed)
- mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
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 |
|---|---|---|
| DexmedetomidineAlso: alpha2-adrenoceptor agonistThe dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia. | Drug | Dexmedetomidine group |
| MidazolamAlso: GABA modulatorsThe midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia. | Drug | Midazolam group |
| SalineAlso: sodium chloride injection (0.9%Nacl)The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia | Drug | Placebo Group |
Primary outcome
Emergence agitation
Time frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.
1 secondary outcome
Postoperative vomiting
Time frame: up to 24 hours
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 6 Jan 2015.
- Derived from this study: PubMed 32976205Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.
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.
Yusheng Yao, M.D. principal investigator
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Midazolam and Saline in people with Inhalational Anesthetics Adverse Reaction and Delirium on Emergence, run by Yao Yusheng 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 1 inclusion and 1 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 6 Jan 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Emergence agitation (time frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895023, which also lists 1 linked publication.
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 6 Jan 2015.