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.: PACTR201611001473594 Date of Approval: 15/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Weight Adjusted Dose versus Fixed Dose Ondansetron in Preventing Shivering Following Spinal Anesthesia for Cesarean Deliveries
Official scientific title Comparison of Weight Adjusted Dose versus Fixed Dose Ondansetron in Preventing Shivering Following Spinal Anesthesia for Cesarean Deliveries
Brief summary describing the background and objectives of the trial ABSTRACT Background Spinal anesthesia is an effective regional anesthesia technique, which is preferred in almost 86% of cesarean sections in the United States and United Kingdom. At least 80% of cesarean sections done at the Aga Khan University hospital are under spinal anesthesia. Shivering is a common complication of spinal anesthesia; it occurs in 40%-64% of patients after neuraxial anesthesia. Shivering may cause maternal and fetal hypoxemia, maternal discomfort and a problem to the anesthesiologists when it comes to monitoring the patient during cesarean sections. Ondansetron a 5ht3 receptor antagonist is effective in treatment and prevention of post anesthesia shivering. In published studies use of fixed dose in patients with different weights in the various groups, masked the dose effect ondansetron in preventing shivering. Such that not adjusting the dose according to the weight of patients in the sample group resulted in a higher occurrence of shivering. No study compares different doses of ondansetron in preventing shivering in parturient women who have had spinal anesthesia for cesarean section. Objectives: To determine if a weight-adjusted dose is better than a fixed dose of ondansetron in preventing shivering following spinal anesthesia for cesarean delivery. Study design: Double blinded Randomized Controlled Trial
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,shivering post spinal anesthesia in women undergoing cesarean section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/08/2015
Actual trial start date 10/08/2015
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date 31/05/2016
Anticipated target sample size (number of participants) 124
Actual target sample size (number of participants) 124
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ref:2015/rec-14(v2) AGA KHAN UNIVERSITY,NAIROBI HEALTH RESEARCH COMMITTEE
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 was done using a computer program, the principal investigator generated a random sequence of numbers. each of the random numbers were sequencially assigned to either. The study drug was prepared by a pharmacist not involved in any other aspect of the study. the pharmacist held the code for randomization and group allocation. Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ONDANSETRON 4MG BEFORE SPINAL ANESTHESIA ONCE BEFORE SPINAL ANESTHESIA PREVENTION OF SHIVERING AFTER SPINAL ANESTHESIA 62 Dose Comparison
Experimental Group ondansetron weight adjusted dose at 0.1mg/kg dose at 0.1mg/kg pre induction prophylaxis against shivering 62 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA 1 and 2 healthy patients over 18 years scheduled for cesarean deliveries under spinal anesthesia. Pre-operative use of ondansetron, tramadol, pethidine, clonidine. This drugs have been used in the prevention and treatment of shivering. Allergy or intolerance to ondansetron. Presence of shivering before drug administration. 18 Year(s) 65 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 10/08/2015 AGA KHAN UNIVERSITY, NAIROBI RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya NAIROBI 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SHIVERING POST SPINAL ANESTHESIA
Secondary Outcome PRURITUS POST SPINAL ANESTHESIA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AGA KHAN UNIVERSITY HOSPITAL NAIROBI 3RD PARKLANDS AVENUE P.O.BOX 30270 GPO (00100) NAIROBI 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
AGA KHAN UNIVERSITY NAIROBI Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya NAIROBI 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AGA KHAN UNIVERSITY NAIROBI Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya NAIROBI 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
PROF VITALIS MUNGAYI Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, KenyaV NAIROBI 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MOSES KIMURI GICHERU GICHERU DRMOKIGI@GMAIL.COM 0723742091 Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya ANESTHESIA RESIDENT
Role Name Email Phone Street address
Public Enquiries KAMANDA CIRU CIRU KAMANDA.CIRU@AKU.EDU 020-366-2148 Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya RESEARCH SUPPORT COORDINATOR
Role Name Email Phone Street address
Scientific Enquiries VITALIS MUNGAYI mungayi@gmail.com +254 733 635554 Aga Khan University, East Africa. 3rd Parklands Avenue P.O. Box 30270 GPO 00100, Nairobi, Kenya
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya PROF,DEPARTMENT OF ANESTHESIA AGA KHAN UNIVERSITY NAIROBI
REPORTING
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