Intravenous Access Time in Pediatric Patients

Intravenous Access Time With the Corresponding Bispectral Index Value During Anesthesia Induction in Pediatric Patients

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.

Study Overview

• Status: Completed
• Conditions: Intravenous Access; Pediatric Patient
• Intervention / Treatment: Behavioral: Intravenous access

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: Zeynep N Orhon, Dr., Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Bispectral index; Sevoflurane; Pediatric patient; Intravenous access
• Other Study ID Numbers: IstanbulMUzeynep1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No