Sevoflurane Agitiion in Pediatric
Conditions
Keywords
sevoflurane, Dexmedetomidine, Propofol
Brief summary
evaluate the synergistic efficacy of propofol and caudal dexmedetomidine for postoperative EA in pediatrics aged from to 2 to 5 years maintained on sevoflurane inhalational anesthesia and scheduled for conginital inguinal hernia repair surgeries
Detailed description
Eligibility and type of the study: This prospective randomized placebo-controlled double-blind study will be conducted after approval from the Institutional Ethics Committee and obtaining written informed consent from parents of children scheduled for conginital inguinal hernia repair procedures under general anesthesia. This study will be conducted at pediatric surgery operating theatre, Assiut University Hospitals. Sample size: Drugs coding and Randomization: Patients will be randomly allocated into three equal groups with the help of a computer-generated table of random numbers to receive the study drugs. One anesthesiologist, not involved in the study procedure or data collection, will prepare the study drugs in identical coded syringes. Access to these codes will be only available to one anesthesiologist who will prepare the syringes according to the study drugs used. To ensure double-blinding, the anesthetic technique and outcome data will be collected by an anesthesiologist not included in preparing study drugs or envelops coding. Also the parents will be blinded to the drug grouping of their children.
Interventions
DRUGdexmedetomidine + propofol
Comparison of caudal dexmedetomidine + propofol sevoflurane-related emergence agitation in children undergoing congenital hernia repair.
DRUGPropofol alone
30 patients will receive propofol 1mg/kg before the start of skin closure, administered over 10 minutes and caudal block using 1 ml/kg of bupivacaine 0. 25 % plus 2 ml normal saline.
DRUGDexmedetomidine
patients will receive caudal dexmedetomidine block using 1 ml/kg of bupivacaine 0. 25 % mixed with dexmedetomidie 1mic/kg diluted in 2 ml normal saline
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 2-7 years * Both genders * American society of anesthesiologists (ASA) physical state I-II * Children undergoing sub-umbilical abdominal surgeries
Exclusion criteria
* Guardians refusal * Congenital anomalies at the lower spine or meninges * Increased intracranial pressure * Skin infection at the site of injection * Bleeding diathesis * Known allergy to any drugs used in this study * Children with behavioral changes; physical or developmental delay; neurological disorder or psychological disorder. * Children on sedative or anticonvulsant medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative EA | 24 hours | The incidence of postoperative emergence agitation in the study groups will be evaluated by using the (PAED Score) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | baseline | will include the study effects on: Hemodynamic parameters, Postoperative pain, Postoperative sedation, Time to the first dose of analgesia postoperatively, Total amount of rescue analgesia in first 24 h postoperatively, Complications, and Parents' satisfaction score. |
Contacts
Primary ContactAbudaif Abdelrazzak Abudaif eid
Outcome results
None listed