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.: PACTR201702002021133 Date of Approval: 06/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Magnesium sulfate
Official scientific title Analgesic and antiemetic effect of Intraperitoneal magnesium sulfate in laparoscopic salpingectomy: a randomized controlled trial
Brief summary describing the background and objectives of the trial to assess the analgesic and antiemetic effect of magnesium sulfate via intraperitoneal instillation in patients undergoing laparoscopic salpingectomy in ectopic pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative analgesia,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/03/2017
Actual trial start date 13/02/2017
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date 06/04/2017
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group , Magnesium sulfate group 20 ml of MgSO4 10% instilled intraperitoneally once intraperitoneal instillation 100
Control Group control group 20 ml of sodium chloride 0.9% instilled intraperitoneally once intraperitoneal instillation 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
hemodynamically-stable patients diagnosed with ectopic pregnancy without any contraindications to laparoscopy were included Criteria for exclusion were presence of psychiatric disease, morbid obesity, heart block, renal impairment, and severe chronic disease. 18 Year(s) 36 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 02/02/2017 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain scores Patient-evaluated incisional, intra-abdominal, and shoulder pain at the first, second, third, sixth, and 12th postoperative hour using VAS.
Primary Outcome Analgesic requirements The time to first analgesic administration, number of analgesic requests in the first 12 h, and total analgesic requirement during the first postoperative 12 h.
Primary Outcome Assessment of nausea and vomiting Nausea was assessed at the same intervals of VAS using a scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt assistant professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt assistant professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt assistant professor of Obstetrics and Gynecology
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