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.: PACTR201510001174606 Date of Approval: 16/06/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title dexamethasone and post operative nausea and vomiting
Official scientific title dexamethasone and post operative nausea and vomiting
Brief summary describing the background and objectives of the trial dexamethasone is known as antiemetic also has analgesic effect. our study will investigate role of preoperative dexamethasone on postoperative nausea and vomiting and also analgesic requirements
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,nausea and vomiting
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/02/2015
Actual trial start date 16/02/2015
Anticipated date of last follow up 09/06/2015
Actual Last follow-up date 11/06/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 intravenous dexamethasone 8 mg once preemptive dexamethasone 25 Historical
Control Group placebo 3 ml once preoperative saline (3ml) 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all patients candiadates for laparoscopic cholecystectomy open cholecystectomy previous ERCP 20 Year(s) 70 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
No 20/06/2015 mansoura faculty ethical committe
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative nausea and vomiting in post anesthesia care unit post operative
Primary Outcome post operative nausea and vomiting POST OPERATIVE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gastroenterology surgical centre Gihan street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
usama elsayed elkods elsharief mansoura
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor usama elsayed Gihan street mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hossam hamed Gihan street mansoura Madagascar
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator usama mohammed usamaelsayed20@yahoo.com 01028842265 elkods elsharief
City Postal code Country Position/Affiliation
mansoura
Role Name Email Phone Street address
Public Enquiries refaey kandeel refaey2@yahoo.com 01028842255 obour street
City Postal code Country Position/Affiliation
mansoura 44444 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries hossam hamed hossamhamed@yahoo.com 01028842244 obour street
City Postal code Country Position/Affiliation
mansoura 44444 Egypt assisstant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information