High vs. Low Flow Sevoflurane Anesthesia in Pediatric Laparoscopic Surgery: Recovery, Hemodynamics, and Cost Comparison

NCT06676969 | Completed

• 1 other identifier: High/Low flow Anestesia
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Our secondary objectives are to evaluate the impact of different flow rates on hemodynamic parameters, ventilation parameters, and costs.

Conditions

Low-flow Anesthesia

Keywords

Laparoscopic surger; Low-flow anesthesia; Pediatric Patient

Outcome Measures

Primary Outcomes (1)

• Recovery times with Aldrete recovery score

  15/09/24-30/11/24

Secondary Outcomes (1)

• Incidence of intraoperative hypothermia by esophageal temperature measurements

  15/09/24-30/11/24

Study Arms (2)

Low flow

Low flow Anestesia

High Flow

High Flow Anestesia

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients undergoing laparoscopic surgery

You may qualify if:

• Patients with an American Society of Anesthesiologists (ASA) classification of I-II.
• Elective laparoscopic surgeries expected to last longer than 30 minutes but shorter than 180 minutes

You may not qualify if:

• Patients who are not candidates for laparoscopic surgery. Patients unsuitable for low-flow anesthesia due to inadequate monitoring conditions.
• Patients whose relatives are unable to provide informed consent. Patients with an American Society of Anesthesiologists (ASA) classification higher than II.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

19 Mayis Üniversitesi Tip Fakültesi

Samsun, 55200, Turkey (Türkiye)

Location

19 Mayıs Üniversitesi Tıp Fakültesi

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (4)

• Isik Y, Goksu S, Kocoglu H, Oner U. Low flow desflurane and sevoflurane anaesthesia in children. Eur J Anaesthesiol. 2006 Jan;23(1):60-4. doi: 10.1017/S026502150500178X.

  PMID: 16390568 BACKGROUND

• Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14.

  PMID: 23277809 BACKGROUND

• Glenski TA, Levine L. The implementation of low-flow anesthesia at a tertiary pediatric center: A quality improvement initiative. Paediatr Anaesth. 2020 Oct;30(10):1139-1145. doi: 10.1111/pan.13994. Epub 2020 Aug 29.

  PMID: 32786105 BACKGROUND

• Meakin GH. Low-flow anaesthesia in infants and children. Br J Anaesth. 1999 Jul;83(1):50-7. doi: 10.1093/bja/83.1.50. No abstract available.

  PMID: 10616333 BACKGROUND

Related Links

• Related Info

Study Design

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

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: May 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 7, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

TU (2)