DexmedetomidinePhase 4NCT05639777
Intranasal Dexmedetomidine in Children Undergoing Adenotonsillectomy Suffering From Mild Upper Respiratory Tract Infection
A Phase 4 study testing Dexmedetomidine group in people with Dexmedetomidine and Adenotonsillectomy, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Adenotonsillectomy, Respiratory Tract Infections
- What is being tested?
- Dexmedetomidine group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2022to 15 May 2023
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with recent mild URI or asthma.
- aged from 3 to 10 years
- ASA Physical Status II,
- undergoing adenotonsillectomy
Who cannot join
- Parental refusal of participation
- Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
- Lower respiratory tract infection
- Congenital heart diseases
- Known hypersensitivity to specific anesthetic agent
- Liver or renal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Eman Ahmed Azzam
Tanta, El-Gharbia, 31527
Eman A Azzam, MD, 0020103743150 ext. 139, eman162092_pg@med.tanta.edu.eg
Ayman A Yousef, MD
About this study
Official title: The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.
Read the detailed description
Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).
Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.
- Being tested
- Dexmedetomidine group, control group
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine groupDrug
Also called Precedex
That will receive intranasal dexmedetomidine (1.5mcg/kg)
control groupOther
That will receive the same volume of 2 ml of intranasal normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intranasal | Experimental | That will receive intranasal dexmedetomidine (1.5mcg/kg) Receives: Drug: Dexmedetomidine group |
| control group | Placebo comparator | That will receive the same volume of 2 ml of intranasal normal saline Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of peri-operative respiratory adverse effects (PRAE).
All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.
Measured: From induction to emergence from general anesthesia.
Secondary outcomes (4)
Sedating effects of this drug.
The sedating effects will be measure using Ramsay sedation scale from 1 to 6 as 1 meaning anxious and agitated, restless, or both. and 6 meaning Unresponsive.
Measured: 15 and 30 min after sedation
Ease of parental separation.
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Measured: 15 and 30 min after sedation
Face mask acceptance.
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
Measured: 15 and 30 min after sedation
Hemodynamic stability
hypertension, tachycardia, bradycardia
Measured: 15 and 30 min after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start6 Dec 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Azzam, Tanta University
- Investigators
- Ayman A Yousef, Professor, Principal investigator, Anesthiology' Surgical Intensive care and Pain MedicineGehan M Eid, Professor, Principal investigator, Assistant Professor Anesthiology' Surgical Intensive care and Pain MedicineWail E Messbah, Lecturer, Principal investigator, Anesthiology' Surgical Intensive care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639777
- Sponsor's protocol ID
- 35355/3/22
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be upon reasonable request from the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT05639777
- Acronym / sponsor ID
- 35355/3/22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 6 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.
The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.
Detailed description
Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).
Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal | Experimental | Drug: Dexmedetomidine groupThat will receive intranasal dexmedetomidine (1.5mcg/kg) |
| control group | Placebo comparator | Other: control groupThat will receive the same volume of 2 ml of intranasal normal saline |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with recent mild URI or asthma.
- aged from 3 to 10 years
- ASA Physical Status II,
- undergoing adenotonsillectomy
Key exclusion criteria (6 listed)
- Parental refusal of participation
- Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
- Lower respiratory tract infection
- Congenital heart diseases
- Known hypersensitivity to specific anesthetic agent
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 |
|---|---|---|
| Dexmedetomidine groupAlso: PrecedexThat will receive intranasal dexmedetomidine (1.5mcg/kg) | Drug | Intranasal |
| control groupThat will receive the same volume of 2 ml of intranasal normal saline | Other | control group |
Primary outcome
The incidence of peri-operative respiratory adverse effects (PRAE).
Time frame: From induction to emergence from general anesthesia.
All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.
4 secondary outcomes
Sedating effects of this drug.
Time frame: 15 and 30 min after sedation
Ease of parental separation.
Time frame: 15 and 30 min after sedation
Face mask acceptance.
Time frame: 15 and 30 min after sedation
Hemodynamic stability
Time frame: 15 and 30 min after sedation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Yes. The data will be upon reasonable request from the principle investigator
Related trials for Dexmedetomidine
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Ayman A Yousef, Professor principal investigator
Anesthiology' Surgical Intensive care and Pain Medicine
Gehan M Eid, Professor principal investigator
Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine
Wail E Messbah, Lecturer principal investigator
Anesthiology' Surgical Intensive care and Pain Medicine
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 group in people with Dexmedetomidine and Adenotonsillectomy, run by Tanta 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 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 7 Dec 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman A Azzam, M․B․B․CH (0020103743150, eman162092_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of peri-operative respiratory adverse effects (PRAE). (time frame: From induction to emergence from general anesthesia.). 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 7 Dec 2022.