Comparing Inhalation and Total Intravenous Anesthesia Methods

Not yet recruiting

• Conditions: Children; Hernia, Inguinal
• Interventions: Device: Target Controlled İnfusion; Drug: Inhalation anesthetic

• Registration Number: NCT06467279
• Lead Sponsor: TC Erciyes University

Brief Summary

comparison of Anesthesia by Target-Controlled Infusion and Inhalation Methods on Pediatric Patients Undergoing Inguinal Hernia Repair: Effects on Patient Outcomes

Detailed Description

COMPARİSON OF THE EFFECT OF ANESTHESİA APPLİED BY TARGET CONTROLLED INFUSİON METHOD AND INHALATİON ANESTHESİA METHOD ON PATİENT OUTCOMES İN PEDİATRİC PATİENTS UNDERGOİNG INGUİNAL HERNİA REPAİR

Study Timeline

• Study First Submitted: 2024-04-16
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Study Start: 2024-07-15
• Primary Completion: 2024-12-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children aged 3-12 years
• Patients weighing over 10 kilograms
• Patients who will undergo inguinal hernia surgery
• ASA (American Society of Anesthesiologists) classification I and II pediatric patients.

Exclusion Criteria

• Absence of systemic illness.
• ASA (American Society of Anesthesiologists) classification III pediatric patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TOTAL INTRAVENOUS ANESTHESIA GROUP	Target Controlled İnfusion	After premedication, anesthesia induction will be performed as per routine. Upon reaching the target Bispectral Index (BIS) level (40-60) and ensuring muscle relaxation, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask airway (LMA). The target concentration of Propofol in the effect site will be set at 3 mcg/ml using a Target-Controlled Infusion (TCI) device. Controlled ventilation will be conducted with 50% oxygen/air mixture, adjusting mechanical ventilation parameters to maintain End-Tidal Carbon Dioxide (EtCO2) levels between 35-45 mmHg.
The Patient Group Receiving Inhalation Anesthesia	Inhalation anesthetic	Patients will be induced with the same anesthesia as Group I, and BIS values will be adjusted to be between 40-60 at the routinely used inhalation gas level of sevoflurane. Patients will be given controlled ventilation with 50% Oxygen/air, and mechanical ventilation materials will be adjusted so that the end tidal carbon dioxide level (EtCO2) will be 35-45 mmHg.

Primary Outcome Measures

Name	Time	Method
Modified Aldrete Scoring System	after surgery 1 hours	The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery.

Secondary Outcome Measures

Name	Time	Method
blood pressure (mmHg)	after surgery 1 hours	The blood pressure of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.
heart rate (Beats/minute)	after surgery 1 hours	The heart rate of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.

Trial Locations

Locations (1)

Özlem OZ GERGİN; 🇹🇷 Kayseri̇, Turkey