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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal | Experimental | That will receive intranasal dexmedetomidine (1.5mcg/kg) |
|
| control group | Placebo Comparator | That will receive the same volume of 2 ml of intranasal normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine group | Drug | That will receive intranasal dexmedetomidine (1.5mcg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of peri-operative respiratory adverse effects (PRAE). | All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded. | From induction to emergence from general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 and 30 min after sedation |
| Ease of parental separation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman A Azzam, M․B․B․CH | Contact | 0020103743150 | eman162092_pg@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ayman A Yousef, Professor | Anesthiology' Surgical Intensive care and Pain Medicine | Principal Investigator |
| Gehan M Eid, Professor | Assistant Professor Anesthiology' Surgical Intensive care and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eman Ahmed Azzam | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be upon reasonable request from the principle investigator
For one year after completion of the study
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| control group | Other | That will receive the same volume of 2 ml of intranasal normal saline |
|
Evaluated using a four-point scale. from 1 to 4 as 1 meaning excellent and 4 for poor
| 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 | 15 and 30 min after sedation |
| Hemodynamic stability | hypertension, tachycardia, bradycardia | 15 and 30 min after sedation |
| Wail E Messbah, Lecturer | Anesthiology' Surgical Intensive care and Pain Medicine | Principal Investigator |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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