Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting
NCT ID: NCT04570592
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
126 participants
INTERVENTIONAL
2020-10-01
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Post surgery, subjects will be monitored in the recovery area for an hour. To supplement ITM as the postoperative analgesia, tablet paracetamol 1g qid and voltaren 50mg tds will be provided to patients postoperatively. The use of opioid is avoided during the first 24 hours of intrathecal morphine administration. Patients will be monitored for complications of ITM for 24 hours and assessments will be carried out by the APS team which include an anaesthetic medical officer and 2 staff nurses.
Assessments are made at 1 hour post surgery, 4 hourly for 12 hours post surgery up to 24 hours after surgery. Episodes of nausea, retching and vomiting will be elicited by direct questioning and recorded at each assessors' visit. Nausea is described as an unpleasant sensation related to the urge to vomit. Retching is defined as an involuntary effort to vomit but without the expulsion of the gastric contents, while vomiting is the when expulsion of gastric contents occur.
The requirement of rescue antiemetics at each time interval will also be documented. Rescue antiemetic is given when a patient developed one or more episodes of vomiting. IV ondansetron 4 mg is given to group A while either IV dexamethasone 4mg or iv ondansetron is given to group B. Subsequent requirement of antiemetics will be decided based on the anaesthetist discretion.
Sample size is calculated based the assumption that the combination of a serotonin receptor antagonist with a corticosteroid would be superior than its monotherapy and thus, the addition of dexamethasone to granisetron would reduce the incidence of PONV from 20% to 3.3%. From the calculation using PS software, the sample required for each group is 57, and with the additional 10% for dropout rate, this study required 63 patients in each group, giving a total of 126 patients.
Data analysis will be performed using SPSS version 27 for MAC. The incidences of nausea, retching, vomiting and the use of rescue antiemetic will be analysed using Chi-Square test. Data is presented as percentage and a p-value of \<0.05 is considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Granisetron
Granisetron 1 mg (1ml) + Normal saline 1ml
Granisetron 1 Mg/mL Intravenous Solution
Comparing PONV incidences in both arms
Granisetron and Dexamethasone
Granisetron 1mg (1ml) + Dexamethasone 4mg (1ml)
Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg
Comparing PONV incidences in both arms
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg
Comparing PONV incidences in both arms
Granisetron 1 Mg/mL Intravenous Solution
Comparing PONV incidences in both arms
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2 risks factors or more for PONV according to Apfel Score.
Exclusion Criteria
* 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).
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universiti Sains Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Farah Nasuha Mohd Daut
Trainee Anaesthetist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Farah Nasuha Mohd Daut
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universiti Sains Malaysia, Health Campus
Kubang Kerian, Kelantan, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Associate Professor W Mohd Nazarudin W Hassan
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, Stoelting RK. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years' experience with 5969 surgical patients at Indiana University Hospital. Anesth Analg. 1999 Mar;88(3):599-604. doi: 10.1097/00000539-199903000-00026.
Sfeir S, Mansour N. Post operative analgesia with intrathecal morphine. Middle East J Anaesthesiol. 2005 Feb;18(1):133-9.
Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
Abouleish E, Rawal N, Fallon K, Hernandez D. Combined intrathecal morphine and bupivacaine for cesarean section. Anesth Analg. 1988 Apr;67(4):370-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
USM/JEPeM/1809426
Identifier Type: -
Identifier Source: org_study_id