Adenotonsillectomy, Children, Emergence Delirium, Magnesium
Conditions
Brief summary
This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Detailed description
Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness. Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent. Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value. In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.
Interventions
cases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
cases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
OTHEROral juice and intravenous saline
cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 4 to 7 years * American Society of Anesthesiologist (ASA) Status I or II * Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Exclusion criteria
* Parents declined to participate in the trial * Behavioral changes, neurological or psychiatric problems * Anticonvulsant or sedative drugs * Physical or developmental abnormalities * Allergies to magnesium * cardiovascular, renal, bone, or gastrointestinal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence delirium | Up to 1 hour after surgery. | Pediatric Anesthesia Emergence Delirium scale will be used and a score \>12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of emergence delirium | Up to 1 hour after surgery. | Pediatric Anesthesia Emergence Delirium scale scores will be recorded |
| Postoperative pain | Up to 1 hour after surgery. | the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl |
| Parental separation anxiety | Perioperative | It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 was considered as 'acceptable' separation |
| Mask acceptance | Perioperative | The ease of mask acceptance will be graded using the Mask Acceptance Score at the time of induction of general anesthesia with sevoflurane. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 was considered 'satisfactory' mask acceptance. |
| The total dose of rescue propofol | Up to 1 hour after surgery. | Parental contact will be initiated as the first line management of delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated. The total dose of rescue propofol will be recorded. |
| The total dose of rescue fentanyl | Up to 1 hour after surgery. | A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded |
| Extubation time | End of surgery. | At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned |
| Negative behavior changes | 24 hours after surgery. | Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours postoperatively. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values. |
| Side effects | Up to 1 hour after surgery. | Postoperative nausea and vomiting , hypotension, bradycardia will be recorded |
Countries
Egypt
Contacts
CONTACTOsama M Rehab, MD
Outcome results
None listed