Clinical trial NCT06734195: Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair
Official title: Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair: Randomized Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sevoflurane Agitiion in Pediatric
Keywords: sevoflurane
Dexmedetomidine
Propofol
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative EA
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: Secondary outcome
timeFrame: baseline
Locations:
Study officials:
affiliation: Assiut University
name: Sherif Sied Abd El rahem, PROF
role: STUDY_CHAIR
affiliation: Assiut University
name: Sara Mohamed Mansour Fathy, DR
role: STUDY_DIRECTOR
References:
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