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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Istanbul
-
Şi̇şli̇、Istanbul、七面鳥、34736
- Nebia Peker
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CHANGE IN P/F
時間枠：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
|
|
CHANGE IN PaCO2
時間枠：from the beginning to the end of anesthesia
|
The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.
|
from the beginning to the end of anesthesia
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
volatile agent consumption amount
時間枠：from the beginning to the end of anesthesia
|
the total amount of volatile agent (sevoflurane) consumed at the end of the surgery
|
from the beginning to the end of anesthesia
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CHANGE IN HR
時間枠：from the beginning to the end of anesthesia
|
Heart rate per minute
|
from the beginning to the end of anesthesia
|
|
CHANGE IN MAP
時間枠：from the beginning to the end of anesthesia
|
Mean arterial pressure
|
from the beginning to the end of anesthesia
|
協力者と研究者
捜査官
- スタディチェア：Nurcan Coşkun、Sisli Hamidiye Etfal Training and Research Hospital
- スタディチェア：Serkan İslamoğlu、Sisli Hamidiye Etfal Training and Research Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Sevoflurane inhalant productの臨床試験
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.募集
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.募集
-
Pennington Biomedical Research CenterSamsung完了