Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201612001896411 Date of Approval: 29/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ondansetron for post-spinal shivering
Official scientific title The role of ondansetron in prevention of post-spinal shivering (PSS) in the obstetric patient: a double blind randomized controlled trial.
Brief summary describing the background and objectives of the trial Elective cesarean delivery (C/D) is most commonly carried on under neuraxial anesthesia, which is commonly associated with shivering, both intra- and postoperatively. The etiology of shivering is not clearly understood, it may involve a combination of mechanisms, including modulation of thermoregulatory thresholds, changes in body heat distribution, reduction in body core temperature, and the cooling effect of the fluids injected into the neuraxis. Severe shivering interferes with electrocardiogram (ECG), pulse oximetry, and monitoring of blood pressure during the critical period of sympathetic block and aortocaval compression, when hypotension is more likely. It may also cause maternal irritability and interfere with her ability to hold her baby. Several drugs are effective in treating or preventing post spinal shivering, including meperidine, tramadol, and clonidine. These drugs have adverse effects on the mother and fetus, including sedation, nausea, vomiting, bradycardia, and hypotension. These unwanted effects limit the use of such drugs before delivery, because of concerns about on the mother and the fetus. Ondansetron, a 5-HT3 antagonists, is a widely used antiemetic during both pregnancy and surgery. Some studies showed its anti-shivering effect following both general and neuraxial anesthesia. It has a potential advantage in the obstetric anesthesia, because of its very low incidence of sedation, hypotension, bradycardia, or risk to the neonate. The prophylactic use of ondansetron to prevent PSS in obstetric patients was investigated by few studies; however, the results were disappointing. The aim of this work was to assess the prophylactic effect of a single intravenous dose of ondansetron (8 mg), compared with placebo, on the prevention of post-spinal shivering during elective cesarean delivery. It also aimed to detect any possible effect of ondansetron on other adverse effects as hypotension, nausea, and vomiting.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-spinal anesthesia shivering,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/08/2016
Actual trial start date 10/08/2016
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 29/11/2016
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IV ondansetron 8 mg, once. Once. intravenous (IV) bolus of the tested drug in 4 mL volume, immediately before induction of spinal anesthesia 25 Placebo
Control Group Normal Saline 0.9% 4 cm. Once Once intravenous (IV) bolus of 4 mL normal saline, immediately before induction of spinal anesthesia 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I or II Full term parturients 20 to 38 years old Scheduled for elective cesarean delivery under spinal anesthesia Complicated pregnancy. Preoperative use of ondansetron or meperidine. Known allergy to the tested drug. Preoperative shivering. Preoperative fever (> 38°C). Hypo- or hyperthyroidism. Parkinson¿s or any extrapyramidal disease. Raynaud¿s syndrome. Intraoperative blood transfusion. Administration of opioids, clonidine, or vasodilator drugs. Adult: 19 Year-44 Year 20 Year(s) 38 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
No 29/11/2016 Kasr Al-Ainy ethics committee
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy st. Cairo 11559 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-spinal shivering during elective cesarean delivery. Intraoperative. Postoperative
Secondary Outcome Nausea and vomiting Intraoperative. Postoperative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Al Ainy st. Cairo 11559 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Anesthesia Kasr Al Ainy st. Cairo 11995 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ali Mokhtar No.7 Al Nady Al Gadid st. New Maadi 11933 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ahmed Badawy Kasr Al Ainy st. Cairo 11559 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Mokhtar alyaly4444@gmail.com 01114999890 No.7 Al Nady Al Gadid st.
City Postal code Country Position/Affiliation
New Maadi 11933 Egypt Lecturer of Anesthesia, Cairo University
Role Name Email Phone Street address
Public Enquiries Ali Mokhtar alyaly4444@gmail.com 01114999890 No.7 Al Nady Al Gadid st.
City Postal code Country Position/Affiliation
New Maadi 11933 Egypt Lecturer of Anesthesia, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ali Mokhtar alyaly4444@gmail.com 01114999890 No.7 Al Nady Al Gadid st.
City Postal code Country Position/Affiliation
New Maadi 11933 Egypt Lecturer of Anesthesia, Cairo University
REPORTING
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