Trial no.:
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PACTR201408000833217 |
Date of Approval:
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21/05/2014 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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the impact of anaesthesia in operative hysteroscopy |
Official scientific title |
The Impact Of Anaesthesia On Haemodynamic And Volume Changes In Operative Hysteroscopy: A Bioimpedance Study . |
Brief summary describing the background
and objectives of the trial
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Operative hysteroscopy is accompanied by the use of distention medium, its absorption can lead to volume overload and haemodynamic disturbances that can lead to serious complications . We will investigate the impact of the type of anaesthesia on decreasing these complications with the use of non invasive thoracic bioimpedance.
60 women ASA I- ¿ undergoing operative hysteroscopy will be randomly allocated into two groups. Spinal anaesthesia group will receive intrathecal 0.5% hyperbaric bupivacaine 12.5 mg and 25 microgram fentanyl, the other group will receive general anaesthesia with intravenous analgesia, propofol and rocuronium followed by endotracheal intubation. Total glycine absorption, cardiac output, systemic vascular resistance and thoracic fluid content ( non invasive thoracic bioimpedance) and serum sodium will be measured.
Spinal anaesthesia is often recommended as a safe choice over general anaesthesia. The haemodynamic benefits of spinal anaesthesia include a minimum decrease in myocardial contractility and only modest decreases in blood pressure and cardiac output.
Thoracic electrical bioimpedance (TEB) retains the significant capability of assessing severely hyper-hydrated and dehydrated patients and detecting pulmonary fluid.
the type of anaesthesia is considered as an important factor that could affect ¿uid absorption. general anaesthesia is associated with more glycine absorption than spinal anaesthesia. In this study we will use TEB for haemodynamic and volume changes monitoring in patients undergoing operative hysteroscopy , comparing the impact of the anaesthetic technique on circulatory glycine load and the incidence of adverse effects
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Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Anaesthesia,hysteroscopy,Obstetrics and Gynecology |
Sub-Disease(s) or condition(s) being studied |
Fertility-female |
Purpose of the trial |
Treatment: Drugs |
Anticipated trial start date |
10/09/2013 |
Actual trial start date |
25/09/2013 |
Anticipated date of last follow up |
12/04/2014 |
Actual Last follow-up date |
28/04/2014 |
Anticipated target sample size (number of participants) |
60 |
Actual target sample size (number of participants) |
60 |
Recruitment status |
Recruiting |
Publication URL |
A.M.El-Attar.Guided isoflurane injection in totally closed circuit.anaesthesia1991;46:1059-63. |
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