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

Phase 4

Not yet recruiting

• Conditions: Sevoflurane Agitiion in Pediatric
• Interventions: Drug: Propofol alone; Drug: Dexmedetomidine; Drug: dexmedetomidine + propofol

• Registration Number: NCT06734195
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2024-12-20
• Primary Completion: 2027-04-10
• Study Completion: 2028-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (propofol group)	Propofol 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.
Group B (caudal dexmedetomidine group)	Dexmedetomidine	30 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.
Group C (propofol with caudal dexmedetomidine group)	dexmedetomidine + propofol	30 patients will receive both propofol .5 mg/kg before the start of skin closure, administered over 10 minutes and caudal dexmedetomidine block using 1 ml/kg of bupivacaine 0. 25 % mixed with dexmedetomidie 1mic/kg diluted in 2 ml normal saline.

Primary Outcome Measures

Name	Time	Method
postoperative EA	24 hours	The incidence of postoperative emergence agitation in the study groups will be evaluated by using the (PAED Score)