NCT04190407

Brief Summary

In pediatric patients with no vascular access, anesthesia induction is usually achieved with sevoflurane. The aim of investigators to evaluate the optimum intravenous access time and the corresponding bispectral index (BIS) value in pediatric surgery under sevoflurane anesthesia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 5, 2019

Last Update Submit

December 8, 2019

Conditions

Keywords

Intravenous accessSevofluraneBispectral indexPediatric patient

Outcome Measures

Primary Outcomes (1)

  • Intravenous access time with the corresponding bispectral index value during anesthesia induction in pediatric patients

    It was evaluated the optimum intravenous access time and the corresponding bispectral index (BIS) value in pediatric surgery under sevoflurane anesthesia.

    12 months

Study Arms (1)

Pediatric patients scheduled for day case surgery

OTHER

A tourniquet was used to raise the vein for entry into the vein every 15 s after the ciliary reflex disappeared. If the patient showed no response to the tourniquet (movement, coughing, or laryngospasm), an experienced anesthesiologist entered a vein in the dorsum of one hand using a 22-24 gauge cannula.

Behavioral: Intravenous access

Interventions

A tourniquet was used to raise the vein for entry into the vein every 15 s after the ciliary reflex disappeared. If the patient showed no response to the tourniquet (movement, coughing, or laryngospasm), an experienced anesthesiologist entered a vein in the dorsum of one hand using a 22-24 gauge cannula.

Pediatric patients scheduled for day case surgery

Eligibility Criteria

Age2 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I or II
  • Age between 2 months to 11 years
  • Patients scheduled for day case surgery (including inguinoscrotal hernia or hydrocele, undescended testis, hypospadias, or routine circumcision)
  • Diagnostic procedures (e.g., cystoscopy) or external ventricular drainage.

You may not qualify if:

  • Obesity
  • Malnutrition
  • Gastroesophageal reflux disease
  • Allergy
  • Sensitivity to volatile anesthetics
  • Procedures lasting more than two hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Zeynep N Orhon, Dr.

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patients with American Society of Anesthesiologists physical status I or II; age between 2 months to 11 years; and scheduled for day case surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 9, 2019

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 31, 2018

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share