NCT05081206

Brief Summary

Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension. All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

August 10, 2021

Last Update Submit

January 25, 2022

Conditions

Propofol Anesthesia in Children

Outcome Measures

Primary Outcomes (1)

  • Depth of anesthesia comparison between two experimental groups.

    Depth of anesthesia will be measured with continuous bispectral index and compared between two experimental groups.

    From anesthesia induction till extubation, every minute up to 90 minutes.

Secondary Outcomes (3)

  • Comparison of blood pressure between two experimental groups.

    At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.

  • Comparison of heart rate between two experimental groups.

    At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.

  • Time to tracheal extubation comparison between two experimental groups.

    5 to 15 minutes after discontinuation of propofol infusion

Study Arms (2)

Manually controlled

EXPERIMENTAL
Drug: Propofol infusion via manually controlled pump.

Target controlled

EXPERIMENTAL
Drug: Propofol infusion via target controlled pump.

Interventions

Propofol infusion via manually controlled pump.DRUG

Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.

Manually controlled
Propofol infusion via target controlled pump.DRUG

Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.

Target controlled

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA score 1 and 2.
  • Planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery,
  • Signed written informed consent for participation in the study by parent and/or legal guardian.

You may not qualify if:

  • Confirmed propofol allergies.
  • Mitochondrial disease
  • Disease of lipid and carbohydrate metabolism
  • Neurological disorders
  • Treated psychiatric comorbidities
  • Hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Belgrade, 11000, Serbia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Anesthesiology and Reanimatology Department

Study Record Dates

First Submitted

August 10, 2021

First Posted

October 18, 2021

Study Start

October 18, 2021

Primary Completion

January 17, 2022

Study Completion

January 24, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)