Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia
Primary Purpose
Hypotension
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Prophylactic ondansetron
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension focused on measuring Ondansetron, Hypotension, Spinal anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 18 and 70 years, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Exclusion Criteria:
- Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
- Patients with atrioventricular block
- Patients with cardiac arrhythmias
- Patients with heart failure;
- Patients with renal disease
- Patients with liver disease
- Patient carrying or suspecting any type of systemic infection or located in a puncture site;
- Patients who refuse to participate in the study after presenting the free and informed consent form;
Sites / Locations
- Hospital de Base do Distrito FederalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ondansetron group
Control group
Arm Description
Patients will receive intravenous ondansetron before spinal anesthesia
Patients will receive intravenous saline before spinal anesthesia
Outcomes
Primary Outcome Measures
Number of participants with adverse events as hypotension
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03973411
Brief Title
Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia
Official Title
Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Base
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Ondansetron, Hypotension, Spinal anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, duble-blind and placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron group
Arm Type
Active Comparator
Arm Description
Patients will receive intravenous ondansetron before spinal anesthesia
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive intravenous saline before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Prophylactic ondansetron
Intervention Description
Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pacients will receibe standard spinal anesthesia
Primary Outcome Measure Information:
Title
Number of participants with adverse events as hypotension
Description
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged between 18 and 70 years, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Exclusion Criteria:
Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
Patients with atrioventricular block
Patients with cardiac arrhythmias
Patients with heart failure;
Patients with renal disease
Patients with liver disease
Patient carrying or suspecting any type of systemic infection or located in a puncture site;
Patients who refuse to participate in the study after presenting the free and informed consent form;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabricio T Mendonça, MD
Phone
5561981882640
Email
correiodofabricio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabricio T Mendonça, MD
Organizational Affiliation
Hospital de Base do Distrito Federal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Base do Distrito Federal
City
Brasilia
State/Province
DF
ZIP/Postal Code
70680250
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamil Elias, MD
Phone
556133151588
Email
uamphbdf@gmail.com
First Name & Middle Initial & Last Name & Degree
Viviane Rezende, MD
Phone
556133151331
Email
vrezende@icab.med.br
12. IPD Sharing Statement
Learn more about this trial
Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia
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