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The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

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ClinicalTrials.gov Identifier: NCT03931863
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
University of Athens
Information provided by (Responsible Party):
Stavroula Karachanidi, Aretaieion University Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Ondansetron 4mg Drug: Ondansetron 8mg Drug: 100ml normal saline 0.9 percent Phase 3

Detailed Description:

The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.

Participants will be randomly assigned to one of the following groups:

Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia

Subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level L3-L4 or L4-L5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. After subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of T4 neurotome and the motor block becomes complete (Bromage grade 3). This time will be called Time to max effect (Tmax).

Hypotension, defined as systolic blood pressure below 100 millimeters of Mercury (mmHg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. Bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg).

Immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. Half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All solutions will be prepared by an independent researcher who will not be further involved in the study eg data collecting or analyzing them. All solutions will look identical to the anesthetist who will administer them to the patients.Apart from the anesthetist, the surgery staff and the researchers recording the measurements will not know the therapeutic intervention team in which each patient has been randomized.
Primary Purpose: Prevention
Official Title: The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
 Drug: Ondansetron 4mg
Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
Other Name: Onda
Active Comparator: Group B
Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
 Drug: Ondansetron 8mg
Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
Other Name: Onda
Placebo Comparator: Group C
Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
 Drug: 100ml normal saline 0.9 percent
Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
Other Name: N/S 0.9 percent


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Systolic Blood Pressure during cesarean section [ Time Frame: 60 minutes ]
    every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery

  2. Change from Baseline Heart Rate [ Time Frame: 60 minutes ]
    every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery


Secondary Outcome Measures :
  1. Sensory blockade [ Time Frame: 20 minutes ]
    Time for onset of sensory block at T4

  2. Motor blockade [ Time Frame: 20 minutes ]
    Time to Bromage 2 and to Bromage 3

  3. Sensory regression [ Time Frame: 120 minutes ]
    Time to two segment regression

  4. Motor block regression [ Time Frame: 120 minutes ]
    Time to Bromage 1 and Bromage 0

  5. Time to maximum effect (Tmax) [ Time Frame: 20 minutes ]
    Time when the motor blockade is complete and sensory blockade is in at the level of T4 dermatome

  6. Time to minimum effect (Tmin) [ Time Frame: 120 minutes ]
    Time to two segment regression of the sensory block (T6) and for motor block regression to Bromage1 and Bromage 0

  7. Nausea [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]
    Scale for nausea (0:no nausea 10:worst possible nausea)

  8. Vomiting [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]
    Number of vomits

  9. Shivering [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]
    Yes:shiver No:no shiver

  10. Total ephedrine consumption [ Time Frame: 60 minutes ]
    Total ephedrine consumption intraoperatively

  11. Total phenylephrine consumption [ Time Frame: 60 minutes ]
    Total phenylephrine consumption intraoperatively

  12. Total atropine consumption [ Time Frame: 60 minutes ]
    Total atropine consumption intraoperatively

  13. Neonate Apgar score [ Time Frame: 5 minutes ]
    Apgar score in the 1st and 5th minute after delivery of the neonate

  14. Umbilical cord ph [ Time Frame: 15 minutes ]
    Umbilical cord ph after delivery

  15. Need for administration of antiemetic agent [ Time Frame: 90 minutes ]
    Need for administration of antiemetic agent intraoperatively


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physical status according to American Society of Anesthesiologists (ASA) I-II
  • Singleton pregnant women in full term pregnancy
  • Patients scheduled for cesarean section
  • Height 158cm-170cm

Exclusion Criteria:

  • patient's own refusal
  • contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
  • ondansetron allergy
  • body mass index> 33kg / m^2
  • height <158cm, or> 170cm
  • hypertensive disorders of pregnancy
  • cardiovascular disease
  • receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine
  • placenta previa.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931863


Contacts
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Contact: Stavroula Karachanidi +306970253686 skarahanidi@gmail.com
Contact: Anteia Paraskeva +306972868078 aparask@med.uoa.gr

Locations
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Greece
Aretaieio Hospital, University of Athens Recruiting
Athens, Attiki, Greece, 11528
Contact: Anteia Paraskeva, MD    +306972868078    aparask@med.uoa.gr   
Principal Investigator: Anteia Paraskeva, MD         
Sponsors and Collaborators
Aretaieion University Hospital
University of Athens
More Information
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Responsible Party: Stavroula Karachanidi, Principal Investigator, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT03931863    
Other Study ID Numbers: 124/17-04-2019
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stavroula Karachanidi, Aretaieion University Hospital:
ondansetron
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
 Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents