HypotensionPhase 3NCT04703088
ONDANSETRON AND EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY
A Phase 3 study testing Ondansetron 4 MG and 0.9% Saline in people with Hypotension and Anesthesia; Adverse Effect, Spinal and Epidural, run by Laval University.
Trial summary
Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in systemic vascular resistance and to the Bezold-Jarisch reflex, which causes hypotension and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension, Anesthesia; Adverse Effect, Spinal and Epidural, Cesarean Section
- What is being tested?
- Ondansetron 4 MG and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Aug 2021
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parturients with a singleton pregnancy at term (37 week's gestation and more)
- elective cesarean delivery under spinal anesthesia
- American Society of Anesthesiologists physical status < III
Who cannot join
- patient refusal
- allergy or hypersensitivity to Norepinephrine or Ondansetron
- Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
- Long QT syndrome or another cause of prolonged QT
- significant preexisting maternal disease (cardiovascular or cerebrovascular disease or coagulopathy, diabetes mellitus)
- pre-existing or pregnancy-induced hypertension
Show all 11Show fewer
- pathological pregnancy (ruptured membranes, pre-eclampsia, placenta praevia, gestational diabetes)
- body mass index < 18 or > 40
- height < 150 or > 180
- fetal abnormalities
- contraindication to spinal anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED STUDY OF THE EFFECT OF A STANDARD DOSE OF INTRAVENOUS ONDANSETRON ON THE EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY
Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in systemic vascular resistance and to the Bezold-Jarisch reflex, which causes hypotension and bradycardia in response to noxious stimuli detected in the cardiac ventricles. In pregnant patients, spinal anesthesia induced hypotension is worsened by compression of the aorta and inferior vena cava by the gravid uterus. In this setting, hypotension could lead to uteroplacental hypoperfusion and fetal distress.
In its 2020 guidelines for enhanced recovery after cesarean section, SOAP states that preventing spinal-induced hypotension is an important strategy to enhance maternal and neonatal outcomes in cesarean delivery
Read more
Recent studies showed that 5-hydroxytryptamine-3 receptor antagonists, mostly used as nausea and vomiting prophylaxis agents, also contributed to inhibit the Bezold-Jarisch reflex and its associated hemodynamic consequences. Ondansetron is the most studied molecule in this field.
Many recent studies and meta-analyses show renewed interest in the use of norepinephrine as a first line agent for preventing and treating spinal anesthesia-induced hypotension in obstetric anesthesia practice instead of phenylephrine. Norepinephrine has the advantage of a better cardiac output and cardiac frequency as compared to phenylephrine without any fetal side effect. The combination of ondansetron and phenylephrine for the prevention of spinal anesthesia-induced hypotension has been studied, but not the combination of ondansetron and norepinephrine.
The main objective of this study is to evaluate the sparing effect of a standard dose of ondansetron on norepinephrine consumption during elective cesarean section under spinal anesthesia by determining the effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion after receiving a single dose of 4 mg of ondansetron or a saline control.
Read the detailed description
Vital signs are measured in the preparation area before entrance in the operation theater. The following measures are taken in the supine position every three minutes for three measures: blood pressure and cardiac frequency. The mean blood pressure and cardiac frequency become the reference measure for each patient.
Upon entrance in the operation theater, anesthesia care is given in a standardized manner:
- Supine positioning of the parturient on the operating table
- Standard monitoring of vitals signs every minute for the time of the study, including systolic, diastolic an mean blood pressures, cardiac frequency and SpO2
- 18G intravenous catheter insertion on the forearm
- Randomization of the patient in one of the two groups followed by blind administration of ondansetron or saline
- 5 minute wait period before sitting the patient for spinal anesthesia
- Standardized spinal anesthesia: Whitacre 25G spinal needle, L4-L5 intervertebral space, hyperbaric bupivacaine 12mg + fentanyl 10 mcg + morphine 100 mcg
- Upon injection of the spinal medication: 1000 ml Ringer lactate coloading and start of the iv norepinephrine infusion upon study protocol.
- Evaluation of the sensitive block level at 5 and 10 minutes, a level of T6 is needed to start surgery
- Nausea and vomiting prophylaxis in both groups with metoclopramide 10 mg and dexamethasone 4 mg if no contraindication. Nausea and vomiting per cesarean section will be treated with dimenhydrinate 25 mg
- Bradycardia (HR below 60) will be treated with atropine 0,4 mg
- Multimodal post-operative analgesia with intra rectal acetaminophen 1000 mg and indomethacin 100 mg
Norepinephrine infusion protocol:
- The rate of the infusion pump is blindly set in mcg/kg/min by one of the investigators before the entrance of the patient and the anesthesia team in the operating room. The setting is hidden from the main physician at all times and the perfusion is started when the spinal medication is injected.
- For the first patient of each group (saline and ondansetron) the norepinephrine infusion is started at 0,05 mcg/kg/min until the end of the study
- Hypotension (as defined as a value inferior or equal to 80% of the systolic blood pressure reference value) is treated by the anesthesiologist with a 4 mcg bolus of norepinephrine from a prepared syringe of norepinephrine 4 mcg/ml
- Hypertension (as defined as a value superior or equal to 120% of the systolic blood pressure reference value) is treated by stopping the norephineprine infusion and restarting it when the value is inferior to 120% of the reference value.
- For the following patients, the norepinephrine infusion rate will be adjusted by up and down allocation following the results of the previous patient: if no hypotension occurred (no bolus needed): the infusion rate is decreased by 0,005 mcg/kg/min (for example from 0,05 mcg/kg/min to 0,045 mcg/kg/min) / if at least one hypotension occurred (at least one bolus needed): the infusion rate is increased by 0,005 mcg/kg/min (for example from 0,05 mcg/kg/min to 0,055 mcg/kg/min)
The study is stopped at the fetal delivery.
- Being tested
- Ondansetron 4 MG, 0.9% Saline
- Keywords
- Spinal Anesthesia, Hypotension, Vascular, Ondansetron Hydrochloride, Norepinephrine, Vasoconstrictor Agents, Cesarean section, Physiological Effects of Drugs, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MGDrug
2 mL of a solution of Ondansetron containing 2mg/ml in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia
0.9% SalineDrug
2 mL of 0,9% Saline in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP - ONDANSETRON | Experimental | 2 mL of a solution of Ondansetron containing 2mg/ml in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia Receives: Drug: Ondansetron 4 MG |
| CONTROL GROUP - NORMAL SALINE | Placebo comparator | 2 mL of 0.9% Saline in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED50 Norepinephrine
The effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion for preventing hypotension in patients who received a single dose of intravenous ondansetron 4mg or saline control five minutes before spinal anesthesia for elective cesarean delivery
Measured: At the fetal delivery
Secondary outcomes (1)
Total consumption of Norepinephrine
The total consumption of Norepinephrine (mcg/kg) in the two groups (pump infusion and bolus)
Measured: At the fetal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study startJun 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized blinded parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Responsible party
- Principal investigator, Romain LANCHON, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703088
- Sponsor's protocol ID
- 2021-5610
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
PubMed 11388543Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
PubMed 20455872Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
PubMed 23135692Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859.
PubMed 11573596Malin GL, Morris RK, Khan KS. Strength of association between umbilical cord pH and perinatal and long term outcomes: systematic review and meta-analysis. BMJ. 2010 May 13;340:c1471. doi: 10.1136/bmj.c1471.
PubMed 20466789Reynolds F, Seed PT. Anaesthesia for Caesarean section and neonatal acid-base status: a meta-analysis. Anaesthesia. 2005 Jul;60(7):636-53. doi: 10.1111/j.1365-2044.2005.04223.x.
PubMed 15960713Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
PubMed 33177330Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PubMed 29090733Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
PubMed 31531852Heesen M, Klimek M, Hoeks SE, Rossaint R. Prevention of Spinal Anesthesia-Induced Hypotension During Cesarean Delivery by 5-Hydroxytryptamine-3 Receptor Antagonists: A Systematic Review and Meta-analysis and Meta-regression. Anesth Analg. 2016 Oct;123(4):977-88. doi: 10.1213/ANE.0000000000001511.
PubMed 27537930Karacaer F, Biricik E, Unal I, Buyukkurt S, Unlugenc H. Does prophylactic ondansetron reduce norepinephrine consumption in patients undergoing cesarean section with spinal anesthesia? J Anesth. 2018 Feb;32(1):90-97. doi: 10.1007/s00540-017-2436-x. Epub 2017 Dec 14.
PubMed 29243058Gao L, Zheng G, Han J, Wang Y, Zheng J. Effects of prophylactic ondansetron on spinal anesthesia-induced hypotension: a meta-analysis. Int J Obstet Anesth. 2015 Nov;24(4):335-43. doi: 10.1016/j.ijoa.2015.08.012. Epub 2015 Aug 22.
PubMed 26421701Qian J, Liu L, Zheng X, Xiao F. Does an Earlier or Late Intravenous Injection of Ondansetron Affect the Dose of Phenylephrine Needed to Prevent Spinal-Anesthesia Induced Hypotension in Cesarean Sections? Drug Des Devel Ther. 2020 Jul 16;14:2789-2795. doi: 10.2147/DDDT.S257880. eCollection 2020.
PubMed 32764878Singh PM, Singh NP, Reschke M, Ngan Kee WD, Palanisamy A, Monks DT. Vasopressor drugs for the prevention and treatment of hypotension during neuraxial anaesthesia for Caesarean delivery: a Bayesian network meta-analysis of fetal and maternal outcomes. Br J Anaesth. 2020 Mar;124(3):e95-e107. doi: 10.1016/j.bja.2019.09.045. Epub 2019 Dec 4.
PubMed 31810562
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED STUDY OF THE EFFECT OF A STANDARD DOSE OF INTRAVENOUS ONDANSETRON ON THE EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY
- ClinicalTrials.gov ID
- NCT04703088
- Acronym / sponsor ID
- 2021-5610
- Keywords
- Spinal Anesthesia, Hypotension, Vascular, Ondansetron Hydrochloride, Norepinephrine, Vasoconstrictor Agents, Cesarean section, Physiological Effects of Drugs, Molecular Mechanisms of Pharmacological Action
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Study start
- Jun 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in systemic vascular resistance and to the Bezold-Jarisch reflex, which causes hypotension and bradycardia in response to noxious stimuli detected in the cardiac ventricles. In pregnant patients, spinal anesthesia induced hypotension is worsened by compression of the aorta and inferior vena cava by the gravid uterus. In this setting, hypotension could lead to uteroplacental hypoperfusion and fetal distress.
In its 2020 guidelines for enhanced recovery after cesarean section, SOAP states that preventing spinal-induced hypotension is an important strategy to enhance maternal and neonatal outcomes in cesarean delivery
Recent studies showed that 5-hydroxytryptamine-3 receptor antagonists, mostly used as nausea and vomiting prophylaxis agents, also contributed to inhibit the Bezold-Jarisch reflex and its associated hemodynamic consequences. Ondansetron is the most studied molecule in this field.
Many recent studies and meta-analyses show renewed interest in the use of norepinephrine as a first line agent for preventing and treating spinal anesthesia-induced hypotension in obstetric anesthesia practice instead of phenylephrine. Norepinephrine has the advantage of a better cardiac output and cardiac frequency as compared to phenylephrine without any fetal side effect. The combination of ondansetron and phenylephrine for the prevention of spinal anesthesia-induced hypotension has been studied, but not the combination of ondansetron and norepinephrine.
The main objective of this study is to evaluate the sparing effect of a standard dose of ondansetron on norepinephrine consumption during elective cesarean section under spinal anesthesia by determining the effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion after receiving a single dose of 4 mg of ondansetron or a saline control.
Detailed description
Vital signs are measured in the preparation area before entrance in the operation theater. The following measures are taken in the supine position every three minutes for three measures: blood pressure and cardiac frequency. The mean blood pressure and cardiac frequency become the reference measure for each patient.
Upon entrance in the operation theater, anesthesia care is given in a standardized manner:
- Supine positioning of the parturient on the operating table
- Standard monitoring of vitals signs every minute for the time of the study, including systolic, diastolic an mean blood pressures, cardiac frequency and SpO2
- 18G intravenous catheter insertion on the forearm
- Randomization of the patient in one of the two groups followed by blind administration of ondansetron or saline
- 5 minute wait period before sitting the patient for spinal anesthesia
- Standardized spinal anesthesia: Whitacre 25G spinal needle, L4-L5 intervertebral space, hyperbaric bupivacaine 12mg + fentanyl 10 mcg + morphine 100 mcg
- Upon injection of the spinal medication: 1000 ml Ringer lactate coloading and start of the iv norepinephrine infusion upon study protocol.
- Evaluation of the sensitive block level at 5 and 10 minutes, a level of T6 is needed to start surgery
- Nausea and vomiting prophylaxis in both groups with metoclopramide 10 mg and dexamethasone 4 mg if no contraindication. Nausea and vomiting per cesarean section will be treated with dimenhydrinate 25 mg
- Bradycardia (HR below 60) will be treated with atropine 0,4 mg
- Multimodal post-operative analgesia with intra rectal acetaminophen 1000 mg and indomethacin 100 mg
Norepinephrine infusion protocol:
- The rate of the infusion pump is blindly set in mcg/kg/min by one of the investigators before the entrance of the patient and the anesthesia team in the operating room. The setting is hidden from the main physician at all times and the perfusion is started when the spinal medication is injected.
- For the first patient of each group (saline and ondansetron) the norepinephrine infusion is started at 0,05 mcg/kg/min until the end of the study
- Hypotension (as defined as a value inferior or equal to 80% of the systolic blood pressure reference value) is treated by the anesthesiologist with a 4 mcg bolus of norepinephrine from a prepared syringe of norepinephrine 4 mcg/ml
- Hypertension (as defined as a value superior or equal to 120% of the systolic blood pressure reference value) is treated by stopping the norephineprine infusion and restarting it when the value is inferior to 120% of the reference value.
- For the following patients, the norepinephrine infusion rate will be adjusted by up and down allocation following the results of the previous patient: if no hypotension occurred (no bolus needed): the infusion rate is decreased by 0,005 mcg/kg/min (for example from 0,05 mcg/kg/min to 0,045 mcg/kg/min) / if at least one hypotension occurred (at least one bolus needed): the infusion rate is increased by 0,005 mcg/kg/min (for example from 0,05 mcg/kg/min to 0,055 mcg/kg/min)
The study is stopped at the fetal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized blinded parallel assignment
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP - ONDANSETRON | Experimental | Drug: Ondansetron 4 MG2 mL of a solution of Ondansetron containing 2mg/ml in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia |
| CONTROL GROUP - NORMAL SALINE | Placebo comparator | Drug: 0.9% Saline2 mL of 0.9% Saline in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- parturients with a singleton pregnancy at term (37 week's gestation and more)
- elective cesarean delivery under spinal anesthesia
- American Society of Anesthesiologists physical status < III
Key exclusion criteria (11 listed)
- patient refusal
- allergy or hypersensitivity to Norepinephrine or Ondansetron
- Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
- Long QT syndrome or another cause of prolonged QT
- significant preexisting maternal disease (cardiovascular or cerebrovascular disease or coagulopathy, diabetes mellitus)
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 |
|---|---|---|
| Ondansetron 4 MG2 mL of a solution of Ondansetron containing 2mg/ml in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia | Drug | INTERVENTION GROUP - ONDANSETRON |
| 0.9% Saline2 mL of 0,9% Saline in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia | Drug | CONTROL GROUP - NORMAL SALINE |
Primary outcome
ED50 Norepinephrine
Time frame: At the fetal delivery
The effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion for preventing hypotension in patients who received a single dose of intravenous ondansetron 4mg or saline control five minutes before spinal anesthesia for elective cesarean delivery
1 secondary outcome
Total consumption of Norepinephrine
Time frame: At the fetal delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background: PubMed 11388543Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001 May;94(5):888-906. doi: 10.1097/00000542-200105000-00030. No abstract available.
- Background: PubMed 20455872Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Background: PubMed 23135692Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
- Background: PubMed 11573596Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859.
- Background: PubMed 20466789Malin GL, Morris RK, Khan KS. Strength of association between umbilical cord pH and perinatal and long term outcomes: systematic review and meta-analysis. BMJ. 2010 May 13;340:c1471. doi: 10.1136/bmj.c1471.
- Background: PubMed 15960713Reynolds F, Seed PT. Anaesthesia for Caesarean section and neonatal acid-base status: a meta-analysis. Anaesthesia. 2005 Jul;60(7):636-53. doi: 10.1111/j.1365-2044.2005.04223.x.
- Background: PubMed 33177330Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
- Background: PubMed 29090733Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
- Background: PubMed 31531852Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
- Background: PubMed 27537930Heesen M, Klimek M, Hoeks SE, Rossaint R. Prevention of Spinal Anesthesia-Induced Hypotension During Cesarean Delivery by 5-Hydroxytryptamine-3 Receptor Antagonists: A Systematic Review and Meta-analysis and Meta-regression. Anesth Analg. 2016 Oct;123(4):977-88. doi: 10.1213/ANE.0000000000001511.
- Background: PubMed 29243058Karacaer F, Biricik E, Unal I, Buyukkurt S, Unlugenc H. Does prophylactic ondansetron reduce norepinephrine consumption in patients undergoing cesarean section with spinal anesthesia? J Anesth. 2018 Feb;32(1):90-97. doi: 10.1007/s00540-017-2436-x. Epub 2017 Dec 14.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron 4 MG and 0.9% Saline in people with Hypotension and Anesthesia; Adverse Effect, Spinal and Epidural, run by Laval University.
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 3 inclusion and 11 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Romain LANCHON (+1 418-525-4444 ext. 47565, romain.lanchon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 Norepinephrine (time frame: At the fetal delivery). 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 NCT04703088, which also lists 29 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 12 Jan 2021.