Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000833217 Date of Approval: 21/05/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 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 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
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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.
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group general anaesthesia 1microg/kg fentanyl, 2 mg/kg propofol and 0.6mg/kg rocuroniumi.v 25 minutes general anaesthesia with endotracheal intubation 30
Experimental Group spinal anaesthesia 12.5 mg 0.5% hyperbaric bupivacaine & 25µg fentanyl 25 minutes sitting spinal anaesthesia L3-4 or L4-5 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult women ASA physical status I-III undergoing operative hysteroscopy suffering from abnormal uterine bleeding Contraindications to spinal anaesthesia contraindications to general anaesthesia contraindications to hysteroscopy Local anaesthetic allergy ASA more than III coagulopathies History of significant cognitive or psychiatric condition that may affect patient assessment Inability to provide informed consent Participation in other clinical studies 20 Year(s) 70 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2013 ethical committee of faculty of medicine,alexandria university
Ethics Committee Address
Street address City Postal code Country
22 Al-Geish Avenue alexandria 21411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the effect of anaesthesia type on the mean total glycine absorption in operative hysteroscopy preoperatively intraoperatively 2 hours postoperatively
Secondary Outcome the effect of anaesthesia on the hemodynamics, TFC , serum sodium and patient ¿ s satisfaction. preoperatively intraoperatively 2 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospital 22, el guish street, el shatby Alexandria 21411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ALEXANDRIA UNIVERSITY 22 Al-Geish Avenue El-Shatby Alexandria 21411 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ALEXANDRIA UNIVERSITY 22 Al-Geish Avenue El-Shatby Alexandria 21411 Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof sahar el karadawy 24 el horeya street Alexandria 21566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ehab moharram haboalex@hotmail.com +2033816319 15 may road,acid city smouha
City Postal code Country Position/Affiliation
alexandria 21522 Egypt lecturer alexandria university
Role Name Email Phone Street address
Public Enquiries ehab moharram haboalex@hotmail.com +2033816319 15 may road,acid city smouha
City Postal code Country Position/Affiliation
alexandria 21522 Egypt leturer alexandria university
Role Name Email Phone Street address
Scientific Enquiries ahmed el-attar a_attar@link.net +2034877435 25 el sultan hussein street el azzarita
City Postal code Country Position/Affiliation
alexandria 21518 Egypt professor of anaesthesia alexandria univesity
REPORTING
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