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出境医 / 临床实验 / Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

Ondansetron in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

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

Condition or disease Intervention/treatment Phase
Hypotension Drug: Prophylactic ondansetron Drug: Placebo Phase 4

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Ondansetron group
Patients will receive intravenous ondansetron before spinal anesthesia
Drug: Prophylactic ondansetron
Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia

Placebo Comparator: Control group
Patients will receive intravenous saline before spinal anesthesia
Drug: Placebo
Pacients will receibe standard spinal anesthesia

Outcome Measures
Primary Outcome Measures :
  1. Number of participants with adverse events as hypotension [ Time Frame: During surgery ]
    Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Fabricio T Mendonça, MD 5561981882640 correiodofabricio@gmail.com

Locations
Layout table for location information
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   
Sponsors and Collaborators
Hospital de Base
Investigators
Layout table for investigator information
Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
Tracking Information
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
 (submitted: June 2, 2019)
Number of participants with adverse events as hypotension [ Time Frame: During surgery ]
Intraoperative hemodynamic stability analysis through the incidence bradycardia, hypotension and consumed vasopressors
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.

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
Condition  ICMJE Hypotension
Intervention  ICMJE
  • Drug: Prophylactic ondansetron
    Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
  • Drug: Placebo
    Pacients will receibe standard spinal anesthesia
Study Arms  ICMJE
  • Active Comparator: Ondansetron group
    Patients will receive intravenous ondansetron before spinal anesthesia
    Intervention: Drug: Prophylactic ondansetron
  • Placebo Comparator: Control group
    Patients will receive intravenous saline before spinal anesthesia
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019)
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:

  • 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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
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