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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

Clinicaltrials.gov identifier NCT03931863

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted October 23, 2019

Study Description

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:Hypotension
  • Intervention/Treatment: Drug: Ondansetron 4mg
    Drug: Ondansetron 8mg
    Drug: 100ml normal saline 0.9 percent
  • Phase: 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
  • Study Type: Interventional
  • Estimated Enrollment: 180 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: May 2022
Arms and interventions
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.
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.
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.
Outcome Measures
  • 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
  • Ages Eligible for Study: 18 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 170cm

- hypertensive disorders of pregnancy

- cardiovascular disease

- receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine

- placenta previa.

Contacts and Locations
Contacts

Contact: Stavroula Karachanidi +306970253686 skarahanidi@gmail.com

Contact: Anteia Paraskeva +306972868078 aparask@med.uoa.gr

Locations

Greece, Attiki
Aretaieio Hospital, University of Athens
Athens

Sponsors and Collaborators

Aretaieion University Hospital

University of Athens

More Information
  • Responsible Party: Aretaieion University Hospital
  • ClinicalTrials.gov Identifier: NCT03931863 History of Changes
  • Other Study ID Numbers: 124/17-04-2019
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: October 23, 2019
  • Last Verified: October 2019
  • 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.: Yes
  • Keywords provided by Aretaieion University Hospital: ondansetron
  • Additional relevant MeSH terms: Hypotension