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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04190407
Other study ID # IstanbulMUzeynep1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2018

Study information

Verified date December 2019
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 31, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 2 Months to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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