- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04813952
The Effect of Minimal Flow Sevoflurane Anesthesia
The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Istanbul
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Şi̇şli̇, Istanbul, Tyrkia, 34736
- Nebia Peker
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: 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.
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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.
Andre navn:
|
Aktiv komparator: 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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
CHANGE IN P/F
Tidsramme: from the beginning to the end of anesthesia
|
PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
P/F ratio is a widely used clinical indicator of hypoxaemia
|
from the beginning to the end of anesthesia
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CHANGE IN PaCO2
Tidsramme: from the beginning to the end of anesthesia
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The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.
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from the beginning to the end of anesthesia
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
volatile agent consumption amount
Tidsramme: from the beginning to the end of anesthesia
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the total amount of volatile agent (sevoflurane) consumed at the end of the surgery
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from the beginning to the end of anesthesia
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
CHANGE IN HR
Tidsramme: from the beginning to the end of anesthesia
|
Heart rate per minute
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from the beginning to the end of anesthesia
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CHANGE IN MAP
Tidsramme: from the beginning to the end of anesthesia
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Mean arterial pressure
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from the beginning to the end of anesthesia
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Nurcan Coşkun, Sisli Hamidiye Etfal Training and Research Hospital
- Studiestol: Serkan İslamoğlu, Sisli Hamidiye Etfal Training and Research Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1019
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