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.: PACTR202203547348725 Date of Approval: 04/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ondansetron versus Acetaminophen for Prevention of Postspinal Anesthesia Shivering in Cesarean Section: A Randmized Controlled Trial
Official scientific title Ondansetron versus Acetaminophen for Prevention of Postspinal Anesthesia Shivering in Cesarean Section: A Randmized Controlled Tria
Brief summary describing the background and objectives of the trial Shivering, which usually occurs as a thermoregulatory response to cold, may occur following general or neuraxial anesthesia. Although shivering may have beneficial thermoregulatory effects, it places the body under increased physiological stress.(1) Shivering also occasionally impedes monitoring techniques, increases intraocular and intracranial pressures. Shivering can double or even triple oxygen consumption and carbon dioxide production also increase metabolic requirement which might predispose to difficulties in patients with existing intrapulmonary shunts, fixed cardiac output or limited respiratory reserve.(2) Postspinal shivering is one of the leading causes of discomfort for patients. Perioperative hypothermia and shivering are usually prevented by physical methods such as surface warming and pharmacologically by drugs such as pethidine, tramadol, clonidine, and ketamine.(3) The neurotransmitter pathways involved in the mechanism of shivering are complex and still poorly understood. Serotonin (5-hydroxytryptamine [5-HT3]), a biologic amine found in the brain and spinal cord, plays a part in neurotransmission of shivering. Ondansetron, 5-HT3 antagonist, is a widely used antiemetic drug. It can be used safely during pregnancy and surgery. Some studies showed its anti-shivering effect following both general and regional anesthesia. (3-4-5) Gholami AS, Hadavi M tested intravenous paracetamol for prevention of shivering after general anethesia in elective caesarean section(6). Although many studies have approved the analgesic effect of intravenous acetaminophen, our study is the first evaluation of intravenous acetaminophen for prevention of postspinal shivering. We hypothesise that acetaminophen might be a good agent for prevention and control of postspinal shivering. It may also reduce the needs for opioids and consequently its related side effects such as sedation, respiratory depression, nausea, and vomiting.
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 17/08/2021
Actual trial start date 02/09/2022
Anticipated date of last follow up 03/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Ondansetron versus Acetaminophen for Prevention of Postspinal Anesthesia Shivering in Cesarean Section: A Randmized Controlled Trial
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 Group P 100 ml Once 30 mintes before the intrathecal anesthesia 100 ml normal saline infused IV 30 minutes before the intrathecal anesthesia 30 Placebo
Experimental Group Group A Acetaminophen 1gm in 100 ml Once 30 minutes before the intrathecal anesthesia Acetaminophen 1gm in 100 ml Once 30 minutes before the intrathecal anesthesia 30
Experimental Group Group O Ondansetron 4mg in 100 ml normal saline Once 30 minutes before the intrathecal anesthesia Ondansetron 4mg in 100 ml normal saline Once 30 minutes before the intrathecal anesthesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status II female patients, 18-40 years old scheduled for caesarean section under spinal anesthesia. fever or hypothermia before the procedure. History of hypertension, cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction . obese patients (BMI ≥30 kg/m2) those who will need intraoperative blood transfusion those with known allergy to any of this study drugs. Any contraindication to neuraxial block Adult: 19 Year-44 Year 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 24/06/2021 Menoufia university faculty of medicine ethics commitee
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghaffar st Shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome occurrence of shivering The shivering severity will be graded as: grade 1(piloerection or peripheral cyanosis, but without visible muscle activity), grade 2 (visible muscle activity confined to one muscle group), grade 3(visible muscle activity in more than one muscle group), or grade 4 (gross muscle activity involving the whole body).Any shivering attack with a score >2 will be treated with Meperidine 25 mg IV. Shivering will be analysed for incidence (number of attacks), severity, time to occur after the intrathecal anesthetic, and its response to meperidine administration. Continuous observation starting from administration of the intrathecal anesthesia till 1 hr postoperatively
Secondary Outcome totally received meperidine doses, the time for first postoperative analgesia request, the occurrence of hypotention or bradycardia, the perioperative complications (nausea, vomiting, dry mouth, dizziness, and desaturation). Starting from the administration of the intrathecal anesthesia till 5 hr postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospitals 25 yasdin abdelghaffar street She in elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principle investigator 25, Yassin abdelghaffar street Shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department 25 yassin abdelghaffar st Shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Gaballah khgaballah@gmail.com 00201016009073 25 yassin abdelghaffar st
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Assistant professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Amany Soltan amany_soltan@gmail.com 002048228305 25 yassin abdelghaffar st
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Asmaa Hamza asmaa_6october@yahoo.com 0020482228305 25 yassin abdelghaffar st
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected data will be available after patient deintificatiom Informed Consent Form,Statistical Analysis Plan,Study Protocol From Start till publication I dependent review commitee Identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Contact the principle investigator at khgaballah@gmail.com 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