Clinical trial NCT04190407: Intravenous Access Time in Pediatric Patients
Official title: Intravenous Access Time With the Corresponding Bispectral Index Value During Anesthesia Induction in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Access
Pediatric Patient
Keywords: Intravenous access
Sevoflurane
Bispectral index
Pediatric patient
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intravenous access time with the corresponding bispectral index value during anesthesia induction in pediatric patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Medeniyet University
name: Zeynep N Orhon, Dr.
role: PRINCIPAL_INVESTIGATOR
References: