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

Not yet recruiting

• Conditions: Laparoscopic Surgery; Target Controlled Infusion
• Interventions: Device: Target Controlled Infusion; Drug: Inhalation anesthetic

• Registration Number: NCT06571682
• Lead Sponsor: TC Erciyes University

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-06-03
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-09-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-30

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 and above pediatric patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Intravenous Anesthesia Group	Target Controlled Infusion	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.
Inhalation Anesthesia Group	Inhalation anesthetic	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.

Primary Outcome Measures

Name	Time	Method
Modified Aldrete Scoring System	Aftet surgery 1 hour	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
Heart rate (beats/minute)	After surgey 1 hour	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.
Blood pressure (mmHg)	After surger 1 hour	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.