Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting After Caesarean Section With Intrathecal Morphine: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Comparing the incidence of post operative nausea and vomiting (PONV)
Study Overview
Brief Summary
Intrathecal morphine (ITM) has proven to be excellent in reducing postoperative pain. However, its use has commonly been associated with the occurrence of postoperative nausea and vomiting (PONV). In recent years, the combination therapy of antiemetics comprising of a serotonin receptor antagonist and corticosteroid has been implemented to diminish the occurrence of PONV. Despite being routinely used, the evidence in the efficacy of this combination in parturients are conflicting and lacking. In this study, we wish to compare the efficacy between the combination therapy of granisetron plus dexamethasone versus granisetron alone on the occurrence of postoperative nausea and vomiting (PONV) in 126 parturients undergoing elective Caesarean delivery supplemented with intrathecal morphine.
Detailed Description
126 parturients aged between 18 and 45 years old who falls within the American Society of Anaesthesiology (ASA) physical status I and II undergoing Caesarean deliveries from the 1st of October 2020 till the 1st of April 2021 will be enrolled. Informed and written consent shall be obtained on recruitment.
Subjects will be randomised using a computer-generated randomisation software using block size 3 into 2 groups; group A and group B each consisting of 63 subjects. The order of interventions within each block was random as determined by computer random number generator. This technique was chosen to ensure similar numbers of patients in each group at any point during the study. Both patients and the assessors of PONV which is the Acute Pain Service (APS) team will be blinded.
Patients are subjected to fasting 6 hours prior to surgery with clear fluid allowed up to 2 hours before surgery. Intravenous (IV) metaclopromide 10mg, IV ranitidine 50mg and mist sodium citrate 30 mls will be administered as part of the acid aspiration prophylaxis. Standard monitoring with continuous noninvasive blood pressure monitoring (NIBP), electrocardiogram (ECG), respiratory rate and pulse oximetry (SpO2) will be implemented throughout anaesthesia.
Ringer's lactate solution 10ml/kg will be infused for coloading to mitigate hypotension post spinal anaesthesia. Spinal anaesthesia will be administered in the upright position, implementing a height-based dose for heavy bupivacaine 0.5% administration. Based on the subject's height, those who are less than 150cm, 151-154cm and those who are more than 155cm will receive 1.5mls, 1.7mls and 1.9mls heavy bupivacaine 0.5% (AstraZeneca) respectively. Fentanyl 15-20 mcg and morphine 0.1 mg are added to supplement the spinal anaesthesia.
On the completion of spinal anaesthesia, 4 mg of dexamethasone will be administered to parturients in group A while group B received 1ml of normal saline injected intravenously. 1mg of IV granisetron will be administered to both groups of subjects after cord clamping. These drugs will be given by the anaesthetist administering the spinal anaethesia. The anaesthetist in charge is not blinded as this is of paramount importance in ensuring patients safety should any complication arises during the delivery of anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •American Society of Anaesthesiologists (ASA) I-II category
- •2 risks factors or more for PONV according to Apfel Score.
Exclusion Criteria
- •Unfit for spinal anaesthesia.
- •Coagulopathy
- •Uncorrected hypovolemia
- •Indeterminate neurologic disease
- •Infection at site of injection
- •Raised intracranial pressure(ICP)
- •Morbidly obese patients, BMI> 40 kg/m2 according to ICD-10 (International Statistical Classification of Diseases 10)
- •Patients allergic towards morphine.
- •Contraindicated for antiemetics use
- •Granisetron: allergy towards Granisetron, prolonged QT interval
- •Ondansetron: allergy towards ondansetron, prolonged QT interval
- •Dexamethasone: allergy towards Dexamethasone, uncontrolled Diabetes Mellitus (DM).
Arms & Interventions
Granisetron
Granisetron 1 mg (1ml) + Normal saline 1ml
Intervention: Granisetron 1 Mg/mL Intravenous Solution (Drug)
Granisetron and Dexamethasone
Granisetron 1mg (1ml) + Dexamethasone 4mg (1ml)
Intervention: Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg (Drug)
Outcomes
Primary Outcomes
Comparing the incidence of post operative nausea and vomiting (PONV)
Time Frame: From 1 to 24 hour post operatively
To compare the incidence of nausea, retching and vomiting at 1 hour, 4 hourly for 12 hours and at 24 hours postoperatively between parturients receiving combination therapy of Granisetron plus Dexamethasone versus that of Granisetron alone
Secondary Outcomes
- Comparing the requirement of rescue antiemetic between both groups(From 1 to 24 hour post operatively)
Investigators
Farah Nasuha Mohd Daut
Trainee Anaesthetist
Universiti Sains Malaysia