Clinical trial NCT03931863: The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
Official title: The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypotension
Keywords: ondansetron
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2019-04-30
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure during cesarean section
timeFrame: 60 minutes
measure: Change from Baseline Heart Rate
timeFrame: 60 minutes
Secondary outcomes:
measure: Sensory blockade
timeFrame: 20 minutes
measure: Motor blockade
timeFrame: 20 minutes
measure: Sensory regression
timeFrame: 120 minutes
measure: Motor block regression
timeFrame: 120 minutes
measure: Time to maximum effect (Tmax)
timeFrame: 20 minutes
measure: Time to minimum effect (Tmin)
timeFrame: 120 minutes
measure: Nausea
timeFrame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
measure: Vomiting
timeFrame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
measure: Shivering
timeFrame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
measure: Total ephedrine consumption
timeFrame: 60 minutes
measure: Total phenylephrine consumption
timeFrame: 60 minutes
measure: Total atropine consumption
timeFrame: 60 minutes
measure: Neonate Apgar score
timeFrame: 5 minutes
measure: Umbilical cord ph
timeFrame: 15 minutes
measure: Need for administration of antiemetic agent
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
Study officials:
References: