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.: PACTR202203695753410 Date of Approval: 04/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study to evaluate the efficacy of dexamethasone versus magnesium sulfate in prevention of post spinal shivering: prospective, randomized, double-blind study
Official scientific title Comparative study to evaluate the efficacy of dexamethasone versus magnesium sulfate in prevention of post spinal shivering: prospective, randomized, double-blind study
Brief summary describing the background and objectives of the trial Shivering is one of the distressing complications of the surgeries performed under regional anesthesia. The reported incidence of shivering ranges from 40% to 70%, in patients undergoing surgery under regional anesthesia.[2,3] Shivering is known to increase oxygen consumption and carbon dioxide production. Besides being distressing to the patients, it also contributes to adverse postoperative events such as wound infection and bleeding [1]. Dexamethasone has an anti-inflammatory, analgesic effects and improved post discharge quality of recovery. It reduces the gradient between skin and body core temperature and modifies the inflammatory response, so it can be effective in reducing postspinal shivering [2]. Magnesium sulfate has drawn attention in the field of anesthesia and pain medicine since 1996. Magnesium being a calcium competitor and N‑methyl D‑Aspartate receptor antagonist, it may reduce shivering threshold. It is also a mild muscle relaxant [3]. Although many pharmacological agents have been used to treat or prevent postspinal anesthesia shivering (PSAS), the ideal treatment was not found. This study evaluated the efficacy of dexamethasone and magnesium sulfate to prevent PSAS in patients undergoing lower abdominal and lower limb surgeries.
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 Treatment: Drugs
Anticipated trial start date 04/04/2022
Actual trial start date 04/04/2022
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 147
Actual target sample size (number of participants) 147
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 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
Control Group placebo ) received 100 mL isotonic saline 90min ) received 100 mL isotonic saline 49 Placebo
Experimental Group dexamethasone group received 8 mg in 100 mL isotonic saline 90min received 8 mg in 100 mL isotonic saline 49
Experimental Group magnesium sulfate group received magnesium sulfate 30 mg/kg in 100 mL isotonic saline 90min received magnesium sulfate 30 mg/kg in 100 mL isotonic saline 49
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
) patients aged between 20 and 60 years old both sexes ASA class I or II undergoing elective abdominal and lower limb surgery under spinal anesthesia Patients on opioid therapy, central nervous system depressants, or with physical dependence on opioids, hepatic or renal disease, pregnancy or lactation, diabetes mellitus ,and/or bleeding disorder are not included. We also excluded patients refusing or having a contraindication for neuraxial blocks , established respiratory depression; a history of hypersensitivity to one of the drugs and/or not willing to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 22/02/2022 anesthesia and intensive care department
Ethics Committee Address
Street address City Postal code Country
25- yassen abdel ghafar shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of clinically significant PSAS 90min
Secondary Outcome The shivering score, heamodynamic changes and the incidences of complications including nausea, vomiting, bradycardia, hypotension and sedation 90min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofia university hospital 25- yassen abdel ghafar shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha afify 25- yassen abdei ghaffar shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university 25- yassen abdel ghafar shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Immediately following publication, No end date Study Protocol unpredictabe unavailable
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