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NCT Number: 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

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

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine + propofol

Drug

Comparison of caudal dexmedetomidine + propofol sevoflurane-related emergence agitation in children undergoing congenital hernia repair.

Propofol alone

Drug

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.

Dexmedetomidine

Drug

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

Primary outcomes

  1. postoperative EA

    Time frame: 24 hours

    The incidence of postoperative emergence agitation in the study groups will be evaluated by using the (PAED Score)

Other outcomes

  1. Secondary outcome

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abudaif Abdelrazzak Abudaif eid

CONTACT

[email protected]

01159737023 ext. +20

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.