The Effect of Minimal Flow Sevoflurane Anesthesia

NCT ID: NCT04813952

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-05-10

Brief Summary

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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

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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.

Conditions

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Anesthesia; Functional Anesthesia Awareness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group M

Group M is minimal flow anesthesia group with fresh gas flow 0,5 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 0,5 L.min-1 flow under general anesthesia.

Group Type ACTIVE_COMPARATOR

Sevoflurane inhalant product

Intervention Type DRUG

The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.

Group H

Group H is high flow anesthesia group with fresh gas flow 4 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 4 L.min-1 flow under general anesthesia.

Group Type ACTIVE_COMPARATOR

Sevoflurane inhalant product

Intervention Type DRUG

The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.

Interventions

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Sevoflurane inhalant product

The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.

Intervention Type DRUG

Other Intervention Names

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Sevorane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nebia Peker

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurcan Coşkun

Role: STUDY_CHAIR

Sisli Hamidiye Etfal Training and Research Hospital

Serkan İslamoğlu

Role: STUDY_CHAIR

Sisli Hamidiye Etfal Training and Research Hospital

Locations

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Nebia Peker

Şişli, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 27413741 (View on PubMed)

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.

Reference Type RESULT
PMID: 23277809 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/27413741/

Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery

https://pubmed.ncbi.nlm.nih.gov/23277809/

The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery

Other Identifiers

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1019

Identifier Type: -

Identifier Source: org_study_id

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