NCT05420402

Brief Summary

This study evaluates the influence of different dose and methods of propofol on emergence agitation(EA) through a randomized controlled trial when preschool children undergoing ambulatory surgery of inguinal hernia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

June 1, 2022

Last Update Submit

April 12, 2023

Conditions

AnesthesiaSurgery

Keywords

Emergence AgitationAmbulatory SurgeryPreschool ChildrenPropofol

Outcome Measures

Primary Outcomes (1)

  • The incidence of emergence agitation

    Pediatric anesthesia emergence delirium scale (PAED). The total score is 20 points.A score of 10 or above is considered as EA and 15 or above is considered as severe EA.

    Within up to 30 minutes after operation

Secondary Outcomes (2)

  • length of hospital stay

    1 day post surgery

  • The occurrence of adverse reactions

    Within up to 30 minutes after operation

Study Arms (4)

Bolus group A

ACTIVE COMPARATOR

42 participants will receive 1 mg/kg intravenous bolus of propofol 3 min before the end of surgery.

Drug: Propofol bolus

Continuous infusion group

ACTIVE COMPARATOR

42 participants will receive 1 mg/kg continuous intravenous pumping of propofol 3 minutes before the end of the operation, and the pumping time was 3 minutes.

Drug: Propofol continuous infusion

Bolus group B

ACTIVE COMPARATOR

42 participants will receive 1 mg/kg intravenous bolus of propofol at the end of surgery.

Drug: Propofol bolus

Blank Comparator group

NO INTERVENTION

42 participants will not receive propofol

Interventions

Propofol bolusDRUG

A bolus dose of propofol 1 mg/kg was administered intravenously at 3 minutes before the end of the surgery.

Also known as: 3 minutes before the end of the surgery
Bolus group A
Propofol continuous infusionDRUG

1 mg/kg propofol was started by continuous infusion 3 minutes before the end of surgery, and the infusion time was 3 minutes.

Also known as: 3 min intravenous pumping
Continuous infusion group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-5 years
  • ASA classification 1
  • Written informed consent
  • Children undergoing ambulatory surgery of inguinal hernia
  • The operation will take no more than 20 minutes

You may not qualify if:

  • Allergic to drugs used in the study
  • Neurological disorders
  • Congenital heart insufficiency
  • Recent respiratory illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518038, China

Location

Related Publications (11)

  • Fabricant PD, Seeley MA, Rozell JC, Fieldston E, Flynn JM, Wells LM, Ganley TJ. Cost Savings From Utilization of an Ambulatory Surgery Center for Orthopaedic Day Surgery. J Am Acad Orthop Surg. 2016 Dec;24(12):865-871. doi: 10.5435/JAAOS-D-15-00751.

    PMID: 27792057RESULT

  • Shinnick JK, Short HL, Heiss KF, Santore MT, Blakely ML, Raval MV. Enhancing recovery in pediatric surgery: a review of the literature. J Surg Res. 2016 May 1;202(1):165-76. doi: 10.1016/j.jss.2015.12.051. Epub 2016 Jan 12.

    PMID: 27083963RESULT

  • 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: 27798810RESULT

  • 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: 26601849RESULT

  • Jacob Z, Li H, Makaryus R, Zhang S, Reinsel R, Lee H, Feng T, Rothman DL, Benveniste H. Metabolomic profiling of children's brains undergoing general anesthesia with sevoflurane and propofol. Anesthesiology. 2012 Nov;117(5):1062-71. doi: 10.1097/ALN.0b013e31826be417.

    PMID: 22929729RESULT

  • Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6.

    PMID: 26290263RESULT

  • Wu X, Cao J, Shan C, Peng B, Zhang R, Cao J, Zhang F. Efficacy and safety of propofol in preventing emergence agitation after sevoflurane anesthesia for children. Exp Ther Med. 2019 Apr;17(4):3136-3140. doi: 10.3892/etm.2019.7289. Epub 2019 Feb 20.

    PMID: 30930979RESULT

  • van Hoff SL, O'Neill ES, Cohen LC, Collins BA. Does a prophylactic dose of propofol reduce emergence agitation in children receiving anesthesia? A systematic review and meta-analysis. Paediatr Anaesth. 2015 Jul;25(7):668-76. doi: 10.1111/pan.12669. Epub 2015 Apr 27.

    PMID: 25917689RESULT

  • Malarbi S, Stargatt R, Howard K, Davidson A. Characterizing the behavior of children emerging with delirium from general anesthesia. Paediatr Anaesth. 2011 Sep;21(9):942-50. doi: 10.1111/j.1460-9592.2011.03646.x. Epub 2011 Jul 5.

    PMID: 21726352RESULT

  • Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.

    PMID: 20497353RESULT

  • Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.

    PMID: 40090678DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 15, 2022

Study Start

August 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 13, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication and with no end date
Access Criteria
Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal. Proposals should be directed to Dr Jiaxiang Chen; e-mail address:cjxanes@163.com To gain access, data requestors will need to sign a data Access agreement.

Locations

CN(1)