NCT06734195

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
24mo left

Started Dec 2024

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2024May 2028

First Submitted

Initial submission to the registry

December 6, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2028

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

December 6, 2024

Last Update Submit

December 12, 2024

Conditions

Sevoflurane Agitiion in Pediatric

Keywords

sevofluraneDexmedetomidinePropofol

Outcome Measures

Primary Outcomes (1)

  • postoperative EA

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

    24 hours

Other Outcomes (1)

  • Secondary outcome

    baseline

Study Arms (3)

Group A (propofol group)

EXPERIMENTAL

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.

Drug: Propofol alone

Group B (caudal dexmedetomidine group)

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Group C (propofol with caudal dexmedetomidine group)

EXPERIMENTAL

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.

Drug: dexmedetomidine + propofol

Interventions

dexmedetomidine + propofolDRUG

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

Group C (propofol with caudal dexmedetomidine group)
Propofol aloneDRUG

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 A (propofol group)
DexmedetomidineDRUG

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 B (caudal dexmedetomidine group)

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-7 years
  • Both genders
  • American society of anesthesiologists (ASA) physical state I-II
  • Children undergoing sub-umbilical abdominal surgeries

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.

    PMID: 27798810BACKGROUND

  • Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.

    PMID: 25535538BACKGROUND

  • Cao JL, Pei YP, Wei JQ, Zhang YY. Effects of intraoperative dexmedetomidine with intravenous anesthesia on postoperative emergence agitation/delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy: A CONSORT-prospective, randomized, controlled clinical trial. Medicine (Baltimore). 2016 Dec;95(49):e5566. doi: 10.1097/MD.0000000000005566.

    PMID: 27930564BACKGROUND

  • Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.

    PMID: 26601849BACKGROUND

  • Brioni JD, Varughese S, Ahmed R, Bein B. A clinical review of inhalation anesthesia with sevoflurane: from early research to emerging topics. J Anesth. 2017 Oct;31(5):764-778. doi: 10.1007/s00540-017-2375-6. Epub 2017 Jun 5.

    PMID: 28585095BACKGROUND

  • Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24. doi: 10.1046/j.1460-9592.2000.00560.x.

    PMID: 10886700BACKGROUND

  • Feng Z, Shi X, Yan X, Zhu Y, Gu J, Zhu H, Yu W, Zhang S. Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial). Trials. 2021 Nov 16;22(1):811. doi: 10.1186/s13063-021-05743-2.

    PMID: 34784941BACKGROUND

  • Ecoffey C. Safety in pediatric regional anesthesia. Paediatr Anaesth. 2012 Jan;22(1):25-30. doi: 10.1111/j.1460-9592.2011.03705.x. Epub 2011 Sep 20.

    PMID: 21933301BACKGROUND

  • Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.

    PMID: 28337460BACKGROUND

  • Turkyilmaz N, Gurkan Y, Cesur S, Kus A, Solak M. [Ultrasound-guided penile nerve block for pediatric hypospadias surgery]. Agri. 2018 Apr;30(2):97-98. doi: 10.5505/agri.2016.70446. Turkish.

    PMID: 29738062BACKGROUND

  • Yeap E, Pacilli M, Nataraja RM. Inguinal hernias in children. Aust J Gen Pract. 2020 Jan-Feb;49(1-2):38-43. doi: 10.31128/AJGP-08-19-5037.

    PMID: 32008266BACKGROUND

Related Links

MeSH Terms

Interventions

DexmedetomidinePropofol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sherif Sied Abd El rahem, PROF

    Assiut University

    STUDY CHAIR

  • Sara Mohamed Mansour Fathy, DR

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Abudaif Abdelrazzak Abudaif eid

CONTACT

01159737023telldont380@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 16, 2024

Study Start

December 20, 2024

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

May 10, 2028

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share