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.: PACTR201505001102479 Date of Approval: 15/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of hyoscine doses as antisialagogue for patients receiving ketofol sedation undergoing colonoscopy procedures.
Official scientific title Comparative study of hyoscine doses as antisialagogue for patients receiving ketofol sedation undergoing colonoscopy procedures.
Brief summary describing the background and objectives of the trial To compare the effects of different regimens of hyoscine as antisialagogue in patients undergoing ketofol sedation for colonoscopy procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,salivation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 18/04/2015
Actual trial start date
Anticipated date of last follow up 01/08/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 5 mg (group A) 5mg procedure antisialoguge 50 Uncontrolled
Experimental Group 10 mg (group B) 10 mg procedure antisialoguge 50 Uncontrolled
Experimental Group 20 mg (group C) 20mg procedure antisialoguge 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(ASA) physical status ¿-¿¿¿ patients of both sexes aged 20-60 years scheduled for therapeutic or diagnostic colonoscopy under ketofol sedation Patients with allergy to study drugs, cardiovascular disease (hypertension, tachycardia, congestive heart failure, and coronary artery disease), and decompensated hepatic or renal failure, glaucoma and prostatic patients 20 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 05/04/2015 Cairo university
Ethics Committee Address
Street address City Postal code Country
kasr elainy Cairo 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome degree of salivation during the procedure of therapeutic or diagnostic colonoscopy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university Kasr elainy street Cairo 11221 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Kasr elainy street Cairo 1234 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university Kasr elainy street Cairo 1234 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Ali kasr elainy Cairo 1234 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Salama atef.kamel@kasralainy.edu.eg +201001733687 Kasr elainy street
City Postal code Country Position/Affiliation
Cairo 1234 Egypt Lecturer of anesthesia and pain management, Anesthesia department, Cairo university
Role Name Email Phone Street address
Public Enquiries Hassan Ali hassan364@hotmail.com +201001733687 Cairo university
City Postal code Country Position/Affiliation
Cairo 12345 Egypt Lecturer of anesthesia and pain management, Anesthesia department, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Hassan Ali hassan364@hotmail.com +201001733687 Kasr elainy street
City Postal code Country Position/Affiliation
Cairo 1234 Egypt Lecturer of anesthesia and pain management, Anesthesia department, Cairo university
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