Emergence AgitationPhase 4NCT02022488
Sevoflurane Induced Emergence Agitation
A Phase 4 study testing midazolam, alfentanil and ketamine in people with Emergence Agitation, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- midazolam, alfentanil and ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to Aug 2012
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1- 8 years
- American Society of Anesthesiologist (ASA) I-II,
- Patients undergoing procedures below the umbilicus
Who cannot join
- cardiac diseases
- pulmonary diseases
- hepatic diseases
- renal diseases
- psychological or emotional disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.
- Conditions
- Emergence Agitation
- Keywords
- Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| midazolam and alfentanil | Active comparator | Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral) Receives: Drug: midazolam; Drug: alfentanil |
| midazolam and ketamine | Active comparator | Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal) Receives: Drug: midazolam; Drug: ketamine |
| midazolam | Placebo comparator | Midazolam 0.5mg/kg Receives: Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium (PAED) score
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
Measured: 7 months
Secondary outcomes (2)
Parental separation score
Parental separation were evaluated with a 4- point scale in the preoperative period
Measured: 7 months
Mask acceptance
The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Bilgen, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022488
- Sponsor's protocol ID
- 162
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02022488
- Acronym / sponsor ID
- 162
- Conditions
- Emergence Agitation
- Keywords
- Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Dec 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.
Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam and alfentanil | Active comparator | Drug: midazolam, Drug: alfentanilMidazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral) |
| midazolam and ketamine | Active comparator | Drug: midazolam, Drug: ketamineMidazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal) |
| midazolam | Placebo comparator | Drug: midazolamMidazolam 0.5mg/kg |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1- 8 years
- American Society of Anesthesiologist (ASA) I-II,
- Patients undergoing procedures below the umbilicus
Key exclusion criteria (5 listed)
- cardiac diseases
- pulmonary diseases
- hepatic diseases
- renal diseases
- psychological or emotional disorders
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 |
|---|---|---|
| midazolamGroup M | Drug | midazolam, midazolam and alfentanil, midazolam and ketamine |
| alfentanilGroup MA | Drug | midazolam and alfentanil |
| ketamineGroup MK | Drug | midazolam and ketamine |
Primary outcome
Pediatric Anesthesia Emergence Delirium (PAED) score
Time frame: 7 months
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
2 secondary outcomes
Parental separation score
Time frame: 7 months
Mask acceptance
Time frame: 7 months
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 30 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 midazolam, alfentanil and ketamine in people with Emergence Agitation, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
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 5 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 30 Dec 2013. 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 Turkey (Türkiye). 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?
Pediatric Anesthesia Emergence Delirium (PAED) score (time frame: 7 months). 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 30 Dec 2013.