The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

Sponsor

Aretaieion University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03931863

Collaborator

University of Athens (Other)

180

Enrollment

Location

Arms

35.3

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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	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

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 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. 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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Aretaieio Hospital, University of Athens	Athens	Attiki	Greece	11528

Sponsors and Collaborators

Aretaieion University Hospital
University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stavroula Karachanidi, Principal Investigator, Aretaieion University Hospital

ClinicalTrials.gov Identifier:

NCT03931863

Other Study ID Numbers:

124/17-04-2019

First Posted:

Apr 30, 2019

Last Update Posted:

Jan 20, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Stavroula Karachanidi, Principal Investigator, Aretaieion University Hospital

ondansetron

Additional relevant MeSH terms:

Hypotension

Ondansetron

Study Results

No Results Posted as of Jan 20, 2021