A Phase 4 interventional study of Prophylactic ondansetron and Placebo in Hypotension, sponsored by Hospital de Base. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by Hospital de Base · Phase 4, Interventional, and Prevention
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
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.
1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 686 interventional studies indexed under Hypotension.
Browse Hypotension studies →Hospital de Base is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Patients will receive intravenous ondansetron before spinal anesthesia
Drug: Prophylactic ondansetron
Patients will receive intravenous saline before spinal anesthesia
Drug: Placebo
Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
Pacients will receibe standard spinal anesthesia
Number of participants with adverse events as hypotension
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
Time frame: During surgery
Started Mar 2019 (actual). Primary completion is estimated for Mar 2020, 12 months after the start.
Of 69 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 76 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Hospital de Base