AgitationPhase 2/3NCT02720705
Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children
A Phase 2/3 study testing Dexmedetomidine and saline in people with Agitation, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Agitation
- What is being tested?
- Dexmedetomidine and saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Nov 2018
- Phase
- Phase 2/3
- 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
- ASA physical status I-II patients
- aged 2-6 years
- patient scheduled for elective tonsillectomy due to recurrent
- chronic tonsillitis
Who cannot join
- patients with known hypersensitivity to medication drugs
- coagulation disorders
- thrombocytopenia
- significant cardiac
- renal
- pulmonary
- hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.
Read the detailed description
Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.
Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.
The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.
- Conditions
- Agitation
- Being tested
- Dexmedetomidine, saline
- Keywords
- sevoflurane emergence agitation
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
oral dexmedetomidine
salineDrug
Also called 0.9% saline
2ml 0.9% saline administered orally half an hour before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| DEX I | Active comparator | active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation Receives: Drug: Dexmedetomidine |
| Saline Control | Placebo comparator | 2ml oral 0.9%saline half an hour before operation Receives: Drug: saline |
| DEX II | Active comparator | active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The agitation score up to 1hour postoperative.
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.
Measured: first postoperative hour
Secondary outcomes (1)
Pain score assessed using the objective pain scale.
Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min.
Measured: up to 1hour postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2018
- Study completionNov 2018
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 AgitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Halla s Abdel-Ghaffar Abdel-Ghaffar, MD, Principal investigator, assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720705
- Sponsor's protocol ID
- AssuitU
- Status last verified
- Jul 2020
- First submitted
- 17 Mar 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. [Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.
PubMed 31672419
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
- ClinicalTrials.gov ID
- NCT02720705
- Acronym / sponsor ID
- AssuitU
- Conditions
- Agitation
- Keywords
- sevoflurane emergence agitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 28 Mar 2016 (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.
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.
Detailed description
Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.
Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.
The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.
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 |
|---|---|---|
| DEX I | Active comparator | Drug: Dexmedetomidineactive comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation |
| Saline Control | Placebo comparator | Drug: saline2ml oral 0.9%saline half an hour before operation |
| DEX II | Active comparator | Drug: Dexmedetomidineactive comparator receive,1µg/kg dexmedetomidine orally half an hour before operation |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA physical status I-II patients
- aged 2-6 years
- patient scheduled for elective tonsillectomy due to recurrent
- chronic tonsillitis
Key exclusion criteria (7 listed)
- patients with known hypersensitivity to medication drugs
- coagulation disorders
- thrombocytopenia
- significant cardiac
- renal
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: precedexoral dexmedetomidine | Drug | DEX I, DEX II |
| salineAlso: 0.9% saline2ml 0.9% saline administered orally half an hour before induction of anesthesia | Drug | Saline Control |
Primary outcome
The agitation score up to 1hour postoperative.
Time frame: first postoperative hour
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.
1 secondary outcome
Pain score assessed using the objective pain scale.
Time frame: up to 1hour postoperative hour
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 14 Jul 2020.
- Derived from this study: PubMed 31672419Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. [Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.
- Individual participant dataSharing planned: No
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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.
Halla s Abdel-Ghaffar Abdel-Ghaffar, MD principal investigator
assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine and saline in people with Agitation, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 7 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 14 Jul 2020. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The agitation score up to 1hour postoperative. (time frame: first postoperative 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 NCT02720705, 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 14 Jul 2020.