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.: PACTR202003565796463 Date of Approval: 02/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title vit c in mutimodal analgesia
Official scientific title Rule of vitamin C in multimodal analgesia for sleeve gastrectomy patient: prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Gastric sleeve is a common procedure in obesity management. Analgesia post operative is a great challenge. Vit C is antioxidant, neuroprotective act on NMDA receptors. So , it will be helpful in multi modal analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) analgesia
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/02/2020
Actual trial start date
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes 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 oral vit c 500mg every 8 hour for 2 days pre operative and the operative day 500 mg/8h/3days orally 3 days( 2 days pre operative and the operative day) patient will take oral vit c 25
Control Group placebo 3 days(2 days pre operative and the operative day) patient will take placebo for 3 days every 8 hour 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
this study will be conducted on adults both sex ASA I or II aging 18-45 years undergoing laparoscopic sleeve gastrectomy in mansoura university hospitals. • Patient refusal • Allergy to used drugs • Addiction • Cardiopulmonary disorder • Altered liver or kidney function • Altered thyroid function test • Psychological problems. • Complicated procedure Adult: 19 Year-44 Year 18 Year(s) 45 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 15/02/2020 IRB mansoura university
Ethics Committee Address
Street address City Postal code Country
el ghomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total dose morphine consumption for first 24 H. post operative 24 hour post operative
Secondary Outcome frequency of morphine consumption 24 hour post operative
Secondary Outcome VAS 0,1,2,4,8,12,24 HOUR POST OPERATIVE
Secondary Outcome heart rate , mean arterial blood pressure, spo2, nausea, vomiting 0,1,2,4,8,12,24 hour post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gastroentrology surgical center gehan street el mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abou elela khatab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university egypt elghomhoria sreet el mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
gastro entrology surgical center gehan street el mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed abou elela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university
Role Name Email Phone Street address
Scientific Enquiries mohamed abouelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university
Role Name Email Phone Street address
Public Enquiries mohamed manoun Mamoun445@hotmail.com 00201093451597 moheb street
City Postal code Country Position/Affiliation
elmehallah elkobra Egypt lecturer of ananesthesia mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study design , methodology , results Clinical Study Report,Study Protocol 12 month after completion of study through IRB mansoura university
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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