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Intravenous Access Time in Pediatric Patients

NCT ID: NCT04190407

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Patients undergoing anesthesia induction must have at least one vascular access opened for administration of intravenous drugs and fluid. In pediatric patients, fear of needles and anxiety about pain can cause discomfort. For this reason, inhalational anesthetics are commonly used for anesthesia induction in children. An ideal inhalational anesthetic agent should have a smooth and fast onset, little irritation to the respiratory tract, and no undesirable side effects. Sevoflurane meets almost all these criteria, so it is commonly used for anesthesia induction in pediatric patients.

Studies related to the induction of anesthesia with sevoflurane have mostly focused on the ease of LMA insertion, the recovery characteristics, the hemodynamic variabilities, comparison of high and low initial sevoflurane concentrations, and cost comparisons between fixed 8% versus incremental techniques. However, after loss of consciousness, children subjected to early intravenous cannulation during sevoflurane induction can display movement, breath holding, coughing, and even laryngospasm. Only limited data are available in the literature regarding intravenous access time at anesthesia induction. The aim of the present study was to evaluate the bispectral index (BIS) values and sevoflurane concentrations during induction of anesthesia and to determine the optimum intravenous access time in pediatric patients.

Conditions

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Intravenous Access Pediatric Patient

Keywords

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Intravenous access Sevoflurane Bispectral index Pediatric patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with American Society of Anesthesiologists physical status I or II; age between 2 months to 11 years; and scheduled for day case surgery
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pediatric patients scheduled for day case surgery

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.

Group Type OTHER

Intravenous access

Intervention Type BEHAVIORAL

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.

Interventions

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Intravenous access

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Obesity
* Malnutrition
* Gastroesophageal reflux disease
* Allergy
* Sensitivity to volatile anesthetics
* Procedures lasting more than two hours.
Minimum Eligible Age

2 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Nur Orhon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep N Orhon, Dr.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Other Identifiers

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IstanbulMUzeynep1

Identifier Type: -

Identifier Source: org_study_id