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.: PACTR201410000893222 Date of Approval: 25/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between sedation and general anesthesia for endoscopic ear surgery
Official scientific title Comparison between sedation and general anesthesia for endoscopic ear surgery
Brief summary describing the background and objectives of the trial There are few published articles discussing anesthesia in patients under going this kind of new surgery. In addition, general anesthesia carries a greater cost to the hospital and the patient's recovery in the immediate postoperative period is more symptomatic. This approach is usually done under general anesthesia in almost all cases, carrying all the risks of this anesthesia, and other factors involved, such as longer hospital stays and increased morbidity. Another point in this type of surgery is the need of a bloodless field of surgery so hypotensive anesthesia is almost always used Objectives: The purpose of this study is to evaluate the possibility of performing Endoscopic Trans-canal Stapes Surgery under local anesthesia with sedation, comparing the differences with general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat,endoscopic ear surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/09/2014
Actual trial start date
Anticipated date of last follow up 01/11/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
Publication URL
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sedation as needed all the operative time endoscopic ear surgery under sedation 20 Active-Treatment of Control Group
Control Group General anesthesia as needed All the operatvie time endoscopic ear surgery under general anesthesia 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients under going endoscopic ear surgery Any patient with known hypersensitivity to the used drugs 18 Year(s) 60 Year(s) Both
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 01/03/2014 alexandria university ethical committee
Ethics Committee Address
Street address City Postal code Country
elmesala squar alexandria 03 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The end point of this study is to stablish the possibility of doing Endoscopic Trans-canal Stapes surgery with local anesthesia and sedation, discussing the differences and advantages over general anesthesia. at the end of the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university elmasala square alexandria 03 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria university elmasala square alexandria 03 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university elmasala square alexandria 03 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr ahmad omran roshdy alexandria 03 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasser osman yasseralx@hotmail.com 03 01006357996 368 horia st
City Postal code Country Position/Affiliation
alexandria 03 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Shreef Elhady selhadi@hotmail.com 01222185437 112 Elmasala
City Postal code Country Position/Affiliation
Alexandria 03 Egypt Professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Shreef Elhady selhadi@hotmail.com 01222185437 112 Elmasala
City Postal code Country Position/Affiliation
Alexandria 03 Egypt Professor of Anesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information