The Effect of Minimal Flow Sevoflurane Anesthesia
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| ClinicalTrials.gov Identifier: NCT04813952 |
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Recruitment Status :
Completed
First Posted : March 24, 2021
Last Update Posted : July 20, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anesthesia; Functional Anesthesia Awareness | Drug: Sevoflurane inhalant product | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial. |
| Actual Study Start Date : | February 15, 2021 |
| Actual Primary Completion Date : | April 30, 2021 |
| Actual Study Completion Date : | May 10, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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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Drug: 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.
Other Name: Sevorane |
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Active Comparator: 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.
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Drug: 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.
Other Name: Sevorane |
- CHANGE IN P/F [ Time Frame: 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
- CHANGE IN PaCO2 [ Time Frame: from the beginning to the end of anesthesia ]The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.
- volatile agent consumption amount [ Time Frame: from the beginning to the end of anesthesia ]the total amount of volatile agent (sevoflurane) consumed at the end of the surgery
- CHANGE IN HR [ Time Frame: from the beginning to the end of anesthesia ]Heart rate per minute
- CHANGE IN MAP [ Time Frame: from the beginning to the end of anesthesia ]Mean arterial pressure
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813952
| Turkey | |
| Nebia Peker | |
| Şi̇şli̇, Istanbul, Turkey, 34736 | |
| Study Chair: | Nurcan Coşkun | Sisli Hamidiye Etfal Training and Research Hospital | |
| Study Chair: | Serkan İslamoğlu | Sisli Hamidiye Etfal Training and Research Hospital |
Publications of Results:
| Responsible Party: | Nebia Peker, medical doctor, Sisli Hamidiye Etfal Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT04813952 |
| Other Study ID Numbers: |
1019 |
| First Posted: | March 24, 2021 Key Record Dates |
| Last Update Posted: | July 20, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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minimal flow anesthesia laparoscopic cholecystectomy |
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Intraoperative Awareness Intraoperative Complications Pathologic Processes Sevoflurane Platelet Aggregation Inhibitors |
Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |