Emergence AgitationNCT05641376
Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
A study testing Nebulized Dexmedetomidine and Intravenous Dexmedetomidine in people with Emergence Agitation, run by Assiut University at 1 site in Egypt.
Trial summary
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Nebulized Dexmedetomidine and Intravenous Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Dec 2023
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I and II
- Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.
Who cannot join
- Patient's guardian refusal to participate in the study.
- Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- history of sleep apnea
- significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
- Known allergy to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Versus Intravenous Dexmedetomidine for Managing Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.
- Conditions
- Emergence Agitation
- Being tested
- Nebulized Dexmedetomidine, Intravenous Dexmedetomidine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized DexmedetomidineDrug
Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. Treatment will be stopped when the nebulizer began to sputter. At end of nebulizer administration, they will be observed for 30 min before induction of general anaesthesia. then the children will be transferred to the operation room and will receive intravenous (IV) normal saline 0.9% in 10 ml volume over 10 minutes after anesthesia induction.
Intravenous DexmedetomidineDrug
Children will receive nebulized 3 ml of 0.9% normal saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. then the children will be transferred to the operation room and will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Dexmedetomidine | Active comparator | Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia. Receives: Drug: Nebulized Dexmedetomidine |
| Intravenous Dexmedetomidine | Active comparator | Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction. Receives: Drug: Intravenous Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded.
PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.
Measured: 60 minutes
Secondary outcomes (3)
Postoperative pain
Postoperative pain will be recorded using FLACC scale at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU.
Measured: 60 minutes
emergence agitation (EA) onset
Emergence agitation onset time was defined as the interval from the extubation to the occurrence.
Measured: 60 minutes
Emergence Agitation duration
Emergence agitation duration was the time from Emergence agitation onset to its cessation
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aboulfotouh Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641376
- Sponsor's protocol ID
- 60757593
- Status last verified
- Apr 2023
- First submitted
- 29 Nov 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Versus Intravenous Dexmedetomidine for Managing Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
- ClinicalTrials.gov ID
- NCT05641376
- Acronym / sponsor ID
- 60757593
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Dexmedetomidine | Active comparator | Drug: Nebulized DexmedetomidineChildren will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia. |
| Intravenous Dexmedetomidine | Active comparator | Drug: Intravenous DexmedetomidineChildren will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I and II
- Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.
Key exclusion criteria (6 listed)
- Patient's guardian refusal to participate in the study.
- Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- history of sleep apnea
- significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
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 |
|---|---|---|
| Nebulized DexmedetomidineChildren will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. Treatment will be stopped when the nebulizer began to sputter. At end of nebulizer administration, they will be observed for 30 min before induction of general anaesthesia. then the children will be transferred to the operation room and will receive intravenous (IV) normal saline 0.9% in 10 ml volume over 10 minutes after anesthesia induction. | Drug | Nebulized Dexmedetomidine |
| Intravenous DexmedetomidineChildren will receive nebulized 3 ml of 0.9% normal saline 1 h before induction of anaesthesia by standard hospital jet nebulizer via a mouthpiece with a continuous flow of 100% oxygen at 6 L /min for 10-15 min. then the children will be transferred to the operation room and will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction. | Drug | Intravenous Dexmedetomidine |
Primary outcome
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
Time frame: 60 minutes
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.
3 secondary outcomes
Postoperative pain
Time frame: 60 minutes
emergence agitation (EA) onset
Time frame: 60 minutes
Emergence Agitation duration
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized Dexmedetomidine and Intravenous Dexmedetomidine in people with Emergence 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Mohammed, M.D. (01060757593, ahmedfotoh86@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale (time frame: 60 minutes). 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 Apr 2023.