PONVPhase 2NCT04570592
Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting
A Phase 2 study testing Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg and Granisetron 1 Mg/mL Intravenous Solution in people with PONV, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PONV
- What is being tested?
- Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg and Granisetron 1 Mg/mL Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2020to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) I-II category
- 2 risks factors or more for PONV according to Apfel Score.
Who cannot join
- Unfit for spinal anaesthesia.
- Coagulopathy
- Uncorrected hypovolemia
- Indeterminate neurologic disease
- Infection at site of injection
- Raised intracranial pressure(ICP)
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Sains Malaysia, Health Campus
Kubang Kerian, Kelantan, 16150
Associate Professor W Mohd Nazarudin W Hassan, 09-7673000 ext. 6105, nazarudin@usm.my
About this study
Official title: Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting After Caesarean Section With Intrathecal Morphine: A Randomized Controlled Trial
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.
Read the 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.
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
- PONV
- Being tested
- Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg, Granisetron 1 Mg/mL Intravenous Solution
- Keywords
- Caesarean, Morphine, Granisetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mgDrug
Also called Treatment group
Comparing PONV incidences in both arms
Granisetron 1 Mg/mL Intravenous SolutionDrug
Comparing PONV incidences in both arms
| Study group | Role | What they receive |
|---|---|---|
| Granisetron | Placebo comparator | Granisetron 1 mg (1ml) + Normal saline 1ml Receives: Drug: Granisetron 1 Mg/mL Intravenous Solution |
| Granisetron and Dexamethasone | Experimental | Granisetron 1mg (1ml) + Dexamethasone 4mg (1ml) Receives: Drug: Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the incidence of post operative nausea and vomiting (PONV)
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
Measured: From 1 to 24 hour post operatively
Secondary outcomes (1)
Comparing the requirement of rescue antiemetic between both groups
To compare the requirement of rescue antiemetic between 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
Measured: From 1 to 24 hour post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PONVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Nasuha Mohd Daut, Universiti Sains Malaysia
- Investigators
- Farah Nasuha Mohd Daut, Principal investigator, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570592
- Sponsor's protocol ID
- USM/JEPeM/1809426
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be considered for sharing if the data is to be used for related studies.
Publications
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.
PubMed 10072014Sfeir S, Mansour N. Post operative analgesia with intrathecal morphine. Middle East J Anaesthesiol. 2005 Feb;18(1):133-9.
PubMed 15830768Dahl 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.
PubMed 10598635Apfel 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.
PubMed 15190136Abouleish E, Rawal N, Fallon K, Hernandez D. Combined intrathecal morphine and bupivacaine for cesarean section. Anesth Analg. 1988 Apr;67(4):370-4.
PubMed 3354872
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting After Caesarean Section With Intrathecal Morphine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04570592
- Acronym / sponsor ID
- USM/JEPeM/1809426
- Conditions
- PONV
- Keywords
- Caesarean, Morphine, Granisetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granisetron | Placebo comparator | Drug: Granisetron 1 Mg/mL Intravenous SolutionGranisetron 1 mg (1ml) + Normal saline 1ml |
| Granisetron and Dexamethasone | Experimental | Drug: Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mgGranisetron 1mg (1ml) + Dexamethasone 4mg (1ml) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) I-II category
- 2 risks factors or more for PONV according to Apfel Score.
Key exclusion criteria (12 listed)
- Unfit for spinal anaesthesia.
- Coagulopathy
- Uncorrected hypovolemia
- Indeterminate neurologic disease
- Infection at site of injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mgAlso: Treatment groupComparing PONV incidences in both arms | Drug | Granisetron and Dexamethasone |
| Granisetron 1 Mg/mL Intravenous SolutionComparing PONV incidences in both arms | Drug | Granisetron |
Primary outcome
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
1 secondary outcome
Comparing the requirement of rescue antiemetic between both groups
Time frame: From 1 to 24 hour post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 10072014Gwirtz 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.
- Background: PubMed 15830768Sfeir S, Mansour N. Post operative analgesia with intrathecal morphine. Middle East J Anaesthesiol. 2005 Feb;18(1):133-9.
- Background: PubMed 10598635Dahl 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.
- Background: PubMed 15190136Apfel 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.
- Results publication: PubMed 3354872Abouleish E, Rawal N, Fallon K, Hernandez D. Combined intrathecal morphine and bupivacaine for cesarean section. Anesth Analg. 1988 Apr;67(4):370-4.
- Individual participant dataSharing planned: No. IPD will be considered for sharing if the data is to be used for related studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farah Nasuha Mohd Daut principal investigator
Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg and Granisetron 1 Mg/mL Intravenous Solution in people with PONV, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the incidence of post operative nausea and vomiting (PONV) (time frame: From 1 to 24 hour post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570592, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.