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.: PACTR201705002160255 Date of Approval: 30/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative effect of different corticosteroids forms on post operative sore throat after i-gel insertion
Official scientific title A comparative effect of different corticosteroids forms on post operative sore throat after i-gel insertion
Brief summary describing the background and objectives of the trial To evaluate the role of corticosteroids forms and methods of their administration, IV, inhalational and topical in reducing the POST after the use of I-gel as a supraglottic airway device.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,post operative sore throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/01/2015
Actual trial start date 25/01/2015
Anticipated date of last follow up 18/10/2015
Actual Last follow-up date 13/10/2015
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 360
Recruitment status Completed
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 a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group prevention of sore throat by different forms of corticoseroides 2.5 mg up to 2 hours use of betamethasone gel in prventing sore throat 90 Placebo
Control Group prevention of sore throat by different forms of corticoseroides as the same dexamethasone dose up to 2hs use of normal saline in different methods like the methods of corticosteroids intervention 90 Placebo
Experimental Group prevention of sore throat by different forms of corticoseroides 8mg dexametasone up to 2 hours use of inhaled dexamethasone in preventing sore throat 90 Placebo
Experimental Group prevention of sore throat by different forms of corticoseroides 8mg dexametasone up to 2 hours use of IV dexamethasone in preventing sore throat 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
360 patients male and female age 18-60 years patients for surgeries of the oral cavity and pharynx, use of a nasogastric tube, unpredicted or long duration surgeries (greater than 2 hours), visible trauma during intubation, more than three attempts needed at insertion of Igel, morbid obese, patients with diabetes or upper respiratory tract infections patients on antinflamatory or steroid therapy 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 11/01/2015 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
gamal abd el naser shebeen el kom ,Menoufia 21611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the use of corticosteroids by IV route, inhalation or topically before I- gel insertion resulted in reduction of post operative sore throat. s 10/10/2015
Secondary Outcome Topical betamethasone application showed more effective outcome in comparison to IV or inhalation form 10/10/2015
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine ,Menoufia university Gamal abd elnaser street sheeben el kom ,Menoufia 21611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine.Menoufia university Gamal abd el naser street Menoufia 21611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine,Menoufia university Gamal abd el naser street sheeben el kom ,Menoufia 21974 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed aly abdel aziz 29 el essawy street alexandria 21611 Egypt
Ahmed Aly abdelaziz Ahmed 29 el essawy street Alexandria 21611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Amin hatattalla@hotmail.com 00201001445568 el essawy steer
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt prof. of anesthesia ,Menoufia university
Role Name Email Phone Street address
Public Enquiries ezz saleh ezzeldin7@hotmail.com 00201006303178 winget street
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt assistant prof.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ahmed azizahmed152@hotmail.com 00201221345154 29 el essawy street
City Postal code Country Position/Affiliation
Alexandria 21611 Egypt lecturer of anesthesia and intensive care. Menoufia university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information