The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotension
• Intervention / Treatment: Drug: Ondansetron 4mg; Drug: Ondansetron 8mg; Drug: 100ml normal saline 0.9 percent

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stavroula Karachanidi; Phone Number: +306970253686; Email: skarahanidi@gmail.com
• Study Contact Backup: Name: Anteia Paraskeva; Phone Number: +306972868078; Email: aparask@med.uoa.gr

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Recruiting
      • Aretaieio Hospital, University of Athens
      • Contact: Anteia Paraskeva, MD; Phone Number: +306972868078; Email: aparask@med.uoa.gr
      • Principal Investigator: Anteia Paraskeva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: N/S 0.9 percent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Systolic Blood Pressure during cesarean section	every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery	60 minutes
Change from Baseline Heart Rate	every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory blockade	Time for onset of sensory block at T4	20 minutes
Motor blockade	Time to Bromage 2 and to Bromage 3	20 minutes
Sensory regression	Time to two segment regression	120 minutes
Motor block regression	Time to Bromage 1 and Bromage 0	120 minutes
Time to maximum effect (Tmax)	Time when the motor blockade is complete and sensory blockade is in at the level of T4 dermatome	20 minutes
Time to minimum effect (Tmin)	Time to two segment regression of the sensory block (T6) and for motor block regression to Bromage1 and Bromage 0	120 minutes
Nausea	Scale for nausea (0:no nausea 10:worst possible nausea)	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Vomiting	Number of vomits	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Shivering	Yes:shiver No:no shiver	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Total ephedrine consumption	Total ephedrine consumption intraoperatively	60 minutes
Total phenylephrine consumption	Total phenylephrine consumption intraoperatively	60 minutes
Total atropine consumption	Total atropine consumption intraoperatively	60 minutes
Neonate Apgar score	Apgar score in the 1st and 5th minute after delivery of the neonate	5 minutes
Umbilical cord ph	Umbilical cord ph after delivery	15 minutes
Need for administration of antiemetic agent	Need for administration of antiemetic agent intraoperatively	90 minutes

Collaborators and Investigators

• Sponsor: Aretaieion University Hospital
• Collaborators: University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: ondansetron
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: 124/17-04-2019

Drug and device information, study documents

• 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