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.: PACTR202110617970232 Date of Approval: 20/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of Intrathecal Pethidine on Incidence & Severity of Shivering during Cesarean section under Spinal anesthesia in Dilla University Referral Hospital, Randomized controlled trial
Official scientific title effect of Intrathecal Pethidine on Incidence & Severity of Shivering during Cesarean section under Spinal anesthesia from April 2020 to January 2021
Brief summary describing the background and objectives of the trial Shivering is the most common & unpleasant complication of anesthesia with incidence of 70.7% in cesarean section done under Spinal anesthesia which is associated with cardiovascular & respiratory complication. Shivering increases metabolic rate by 600%, intracranial & intraocular pressure, production of carbon dioxide & lactic acidosis, as well as it also increases risk of floating clot, postoperative bleeding, delayed wound healing, and uncomfortable recovery time due to pain. Even though it causes such devastating complication; prevention of shivering is not well investigated. Few study indicated that adding of pethidine with local anesthetic agent during Spinal anesthesia has antishivering property which is mediated by its effect on kappa opioid receptor. effect of Intrathecal Pethidine on Incidence & Severity of Shivering during Cesarean section under Spinal anesthesia from April 2020 to January 2021
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/10/2021
Actual trial start date
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants)
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intrathecal pethidine 10mg during injection of spinal anesthesea only giving 10mg of preservative free pethidine with bupivacaine 43
Control Group control bupivacaine 12.5mg alone during injection with out pethidine 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All elective ASA I & II pregnant mother Initial body temperature <36 & > 38 degree Celsius, Allergy history to pethidine & LA agent Patient who received thermoregulatory medication or antipsychotic medication, History of alcohol or substance abuse History of cardiovascular disease Preclampsia, Antepartum hemorrhage Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 10/04/2021 instutitional review board of Dilla University
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 13 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence and severity of shivering from induction to PACU stay time
Secondary Outcome postoperative nausea and vomitingpruritus 6hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
dilla university referral hospita dilla dilla 6070 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla 13 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla 13 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Timsel Girma timsikebron15@gmail.com +251944060952 dilla
City Postal code Country Position/Affiliation
dilla 13 Ethiopia principal investigator
Role Name Email Phone Street address
Public Enquiries Timsel Girma timsikebron15@gmail.com +251944060952 dilla
City Postal code Country Position/Affiliation
dilla Ethiopia principal investigator
Role Name Email Phone Street address
Scientific Enquiries Timsel Girma timsikebron15@gmail.com +251944060952 dilla
City Postal code Country Position/Affiliation
dilla Ethiopia principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual information is saved in secured place and shared if there is request Informed Consent Form,Study Protocol all of the time for mandatory purpuse
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/02/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information