Comparing Inhalation and Total Intravenous Anesthesia Methods

NCT06467279 | Completed

• 2 other identifiers: 2022/200TDK-2022-11979
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effects of anesthesia using target-controlled infusion (TCI) and inhalation methods on pediatric patients undergoing inguinal hernia repair. The main outcomes include intraoperative hemodynamic stability and postoperative recovery characteristics. Sixty children were randomized to receive either total intravenous anesthesia (TIVA) via the Eleveld model or inhalation anesthesia with sevoflurane. The study aims to evaluate which method is safer and more effective in pediatric surgical anesthesia.

Conditions

Children; Hernia, Inguinal

Keywords

BIS; TIVA; İNFUSİON; İNGUİNAL HERNİA

Outcome Measures

Primary Outcomes (1)

• Modified Aldrete Scoring System

  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.

  after surgery 1 hours

Secondary Outcomes (2)

• blood pressure (mmHg)

  after surgery 1 hours

• heart rate (Beats/minute)

  after surgery 1 hours

Study Arms (2)

TOTAL INTRAVENOUS ANESTHESIA GROUP

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.

Device: Target Controlled İnfusion

The Patient Group Receiving Inhalation Anesthesia

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.

Drug: Inhalation anesthetic

Interventions

Target Controlled İnfusion DEVICE

TCI (Target-Controlled Infusion) is a method used to maintain the dose and rate of anesthesia drugs within a target concentration range set by the anesthetist. This system delivers drugs intravenously to the patient using a computer-controlled pump. The anesthetist adjusts the drug concentration to achieve the desired depth of anesthesia. This method provides more precise control over anesthesia and facilitates maintaining the depth of anesthesia within the desired range.

Also known as: TCI

TOTAL INTRAVENOUS ANESTHESIA GROUP

Inhalation anesthetic DRUG

In the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction.

Also known as: Sevoflurane

The Patient Group Receiving Inhalation Anesthesia

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 3-12 with ASA I-II undergoing inguinal hernia repair.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Özlem OZ GERGİN

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthetics, Inhalation; Sevoflurane

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Özlem OZ GERGİN, MD

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: June 20, 2024
• Study Start: August 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

TU (1)