Clinical trial NCT04813952: The Effect of Minimal Flow Sevoflurane Anesthesia
Official title: The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Functional
Anesthesia Awareness
Keywords: minimal flow anesthesia
laparoscopic cholecystectomy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: they will divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1.
Primary purpose: TREATMENT

Brief summary: Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Detailed description: Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation.

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) class I-II
* The operation time between 60-180 minutes

Exclusion Criteria:

* Severe cardiac disease
* COPD (Chronic Obstructive Pulmonary Disease)
* Severe liver and kidney disease,
* Diabetes mellitus
* Morbid obesity
* Alcohol and/or drug addiction
* Risk or history of malignant hyperthermia
* Pregnancy and lactation
* Emergency cases
* Operation time less than 60 minutes and longer than 180 minutes

Primary outcomes:
measure: CHANGE IN P/F
timeFrame: from the beginning to the end of anesthesia
measure: CHANGE IN PaCO2
timeFrame: from the beginning to the end of anesthesia
Secondary outcomes:
measure: volatile agent consumption amount
timeFrame: from the beginning to the end of anesthesia
Other outcomes:
measure: CHANGE IN HR
timeFrame: from the beginning to the end of anesthesia
measure: CHANGE IN MAP
timeFrame: from the beginning to the end of anesthesia
Locations:
city: Şi̇şli̇
country: Turkey
facility: Nebia Peker
state: Istanbul
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Nurcan Coşkun
role: STUDY_CHAIR
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Serkan İslamoğlu
role: STUDY_CHAIR
References:
citation: Doger C, Kahveci K, Ornek D, But A, Aksoy M, Gokcinar D, Katar D. Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery. Biomed Res Int. 2016;2016:3068467. doi: 10.1155/2016/3068467. Epub 2016 Jun 20.
citation: 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.