Condition or disease | Intervention/treatment | Phase |
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Hypotension | Drug: Prophylactic ondansetron Drug: Placebo | Phase 4 |
Spinal anesthesia is usually the first choice for many surgical procedures of lower limbs, perineum, and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia.
Hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers. The Bezold-Jarisch reflex, proposed as a mechanism for bradycardia is mediated by serotonin receptors (subtype 5-HT3) located in the vagus nerve and within the walls of the cardiac ventricles. 5-HT3 receptors are activated in response to systemic hypotension, causing increased vagal efferent signaling, bradycardia, reduced cardiac output and increased exacerbation of hypotension.
Therefore, ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic, is potentially useful in attenuating this response. To assess this response, the main goal of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension.
This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that blocking serotonin type 3 receptors with intravenous ondansetron prior to subarachnoid block reduces hypotension induced by spinal anesthesia in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used.
Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug.
Patients will receive standard monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. The study drug (ondansetron 0.15 mg / kg or placebo) will then be administered. All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist.
The evolution of vital signs such as systolic blood pressure, mean heart rate, height of the sensitive block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, vasopressor and antiemetic consumption will be evaluated.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, randomized, duble-blind and placebo-controlled trial |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | March 2020 |
Arm | Intervention/treatment |
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Active Comparator: Ondansetron group
Patients will receive intravenous ondansetron before spinal anesthesia
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Drug: Prophylactic ondansetron
Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
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Placebo Comparator: Control group
Patients will receive intravenous saline before spinal anesthesia
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Drug: Placebo
Pacients will receibe standard spinal anesthesia
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fabricio T Mendonça, MD | 5561981882640 | correiodofabricio@gmail.com |
Brazil | |
Hospital de Base do Distrito Federal | Recruiting |
Brasilia, DF, Brazil, 70680250 | |
Contact: Jamil Elias, MD 556133151588 uamphbdf@gmail.com | |
Contact: Viviane Rezende, MD 556133151331 vrezende@icab.med.br |
Principal Investigator: | Fabricio T Mendonça, MD | Hospital de Base do Distrito Federal |
Tracking Information | |||||
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First Submitted Date ICMJE | May 29, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | June 4, 2019 | ||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events as hypotension [ Time Frame: During surgery ] Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia | ||||
Official Title ICMJE | Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial | ||||
Brief Summary | Ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic. The main objective of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension | ||||
Detailed Description |
Spinal anesthesia is usually the first choice for many surgical procedures of lower limbs, perineum, and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. Hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers. The Bezold-Jarisch reflex, proposed as a mechanism for bradycardia is mediated by serotonin receptors (subtype 5-HT3) located in the vagus nerve and within the walls of the cardiac ventricles. 5-HT3 receptors are activated in response to systemic hypotension, causing increased vagal efferent signaling, bradycardia, reduced cardiac output and increased exacerbation of hypotension. Therefore, ondansetron, a potent 5-HT 3 receptor antagonist commonly used as an antiemetic, is potentially useful in attenuating this response. To assess this response, the main goal of the present study is to verify the hypothesis that blocking type 3 serotonin receptors with intravenous ondansetron reduces the incidence of spinal anesthesia-induced hypotension. This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that blocking serotonin type 3 receptors with intravenous ondansetron prior to subarachnoid block reduces hypotension induced by spinal anesthesia in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used. Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug. Patients will receive standard monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. The study drug (ondansetron 0.15 mg / kg or placebo) will then be administered. All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist. The evolution of vital signs such as systolic blood pressure, mean heart rate, height of the sensitive block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, vasopressor and antiemetic consumption will be evaluated. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, randomized, duble-blind and placebo-controlled trial Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention |
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Condition ICMJE | Hypotension | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2020 | ||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Brazil | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03973411 | ||||
Other Study ID Numbers ICMJE | Ondansetron for spinal | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Fabricio Tavares Mendonca, Hospital de Base | ||||
Study Sponsor ICMJE | Hospital de Base | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hospital de Base | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |