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.: PACTR201808847015879 Date of Approval: 13/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the effect of intraoperative dextrose 10% administration on reducing post-operative nausea and vomiting after laparoscopic surgery.
Official scientific title intraoperative dextrose to reduce post-operative nausea and vomiting.
Brief summary describing the background and objectives of the trial laparoscopic surgery is accompanied with postoperative nausea and vomiting the best way to decrease it is not yet known that's why we are evaluating intraoperative dextrose administration
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/08/2018
Actual trial start date
Anticipated date of last follow up 18/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
Recruitment status Not yet 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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group antiemetic medication 125ml/h 2 hours dextrose 10% administration 65
Control Group placebo 125ml/h 2 hours lactated ringer solution 65 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
non smoker ASA I, II female 20-40 years of age undergoing laparoscopic surgery morbid obesity severe hypertension congestive heart failure coagulopathy significant hepatic or renal disease diabetes mellitus, abnormal blood glucose on the morning of surgery withdrawal of consent severe intraoperative hypotension requiring large volume intravascular fluid treatment whose operations were prolonged (more than 2 h) random blood sugar elevated to > or = 200 mg% previous history of postoperative nausea and vomiting (PONV) currently receiving steroids or antiemetics pregnant or menstruating Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Female
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 14/08/2018 AIN shams university research ethics committee
Ethics Committee Address
Street address City Postal code Country
abbasyia cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare the incidence and severity of postoperative nausea and vomiting in study groups every half hour in first 4 hours then after discharge from PACU at 6,12 24 hours
Secondary Outcome anti emetic medication consumption,blood glucose changes between groups all antiemetic recieved during PACU stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital abbasyia street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ashraf nabil abbasya cairo 11566 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf nabil ashraf_nabel@med.asu.edu.eg +201001100613 fifth settlement
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Public Enquiries dalia fahmy daliafahmy78@gmail.com +201005183655 nasr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Scientific Enquiries mohamed kamal dr_medo2000@hotmail.com +201003787898 nasr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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