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

NCT06571682 | Not Yet Recruiting

• 1 other identifier: 2022/354
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Laparoscopic Surgery; Target Controlled Infusion

Keywords

Pediatric Laparoscopic Surgery; Target Controlled Infusion; Propofol; Sevoflurane

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.

  Aftet surgery 1 hour

Secondary Outcomes (2)

• Blood pressure (mmHg)

  After surger 1 hour

• Heart rate (beats/minute)

  After surgey 1 hour

Study Arms (2)

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

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

Interventions

Target Controlled Infusion 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

Inhalation Anesthesia Group

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 laparoscopic surgery

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 and above pediatric patients.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Interventions

Anesthetics, Inhalation; Sevoflurane

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

Central Study Contacts

Özlem OZ GERGIN, MD

CONTACT

09005332466396; oozgergin@erciyes.edu.tr

Study Design

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

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: August 26, 2024
• Study Start: September 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08