Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

Comparison of the Effect of Anesthesia Applied by Target Controlled Infusion Method and Inhalation Anesthesia Method on Patient Outcomes in Pediatric Patients Undergoing Laparoscopic Surgery

Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery; Target Controlled Infusion
• Intervention / Treatment: Drug: Inhalation anesthetic; Device: Target Controlled Infusion

Detailed Description

In pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (TIVA) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; It is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Özlem OZ GERGIN, MD; Phone Number: 09005332466396; Email: oozgergin@erciyes.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children aged 3-12 with ASA I-II undergoing laparoscopic surgery

Description

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 and above pediatric patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Intravenous Anesthesia Group; Patients will undergo anesthesia induction as routine after premedication. Once the target BIS level is reached (40-60) and muscle relaxation is achieved, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask (LMA). The effect zone target concentration of propofol will be adjusted to 3 mcg/ml with the HKI device. Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 35-45 mmHg.	Device: Target Controlled Infusion; 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.; Other Names: TCI
Inhalation Anesthesia Group; Patients will undergo anesthesia induction as routine after premedication. The level of sevoflurane, an inhalation gas, will be adjusted so that BIS values are between 40-60. Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 35-45 mmHg.	Drug: Inhalation anesthetic; In the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction.; Other Names: Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Aftet surgery 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (mmHg)	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.	After surger 1 hour
Heart rate (beats/minute)	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.	After surgey 1 hour

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: Özlem OZ GERGİN, MD, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; Target Controlled Infusion; Pediatric Laparoscopic Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Platelet Aggregation Inhibitors; Anesthetics; Sevoflurane; Anesthetics, Inhalation
• Other Study ID Numbers: 2022/354

Drug and device information, study documents

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