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The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypotension | Drug: Ondansetron 4mg Drug: Ondansetron 8mg Drug: 100ml normal saline 0.9 percent | Phase 3 |
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 (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 |
| 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
|
- 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
- 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
- Sensory blockade [ Time Frame: 20 minutes ]Time for onset of sensory block at T4
- Motor blockade [ Time Frame: 20 minutes ]Time to Bromage 2 and to Bromage 3
- Sensory regression [ Time Frame: 120 minutes ]Time to two segment regression
- Motor block regression [ Time Frame: 120 minutes ]Time to Bromage 1 and Bromage 0
- 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
- 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
- Nausea [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]Scale for nausea (0:no nausea 10:worst possible nausea)
- Vomiting [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]Number of vomits
- Shivering [ Time Frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively ]Yes:shiver No:no shiver
- Total ephedrine consumption [ Time Frame: 60 minutes ]Total ephedrine consumption intraoperatively
- Total phenylephrine consumption [ Time Frame: 60 minutes ]Total phenylephrine consumption intraoperatively
- Total atropine consumption [ Time Frame: 60 minutes ]Total atropine consumption intraoperatively
- Neonate Apgar score [ Time Frame: 5 minutes ]Apgar score in the 1st and 5th minute after delivery of the neonate
- Umbilical cord ph [ Time Frame: 15 minutes ]Umbilical cord ph after delivery
- Need for administration of antiemetic agent [ Time Frame: 90 minutes ]Need for administration of antiemetic agent intraoperatively
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Stavroula Karachanidi | +306970253686 | skarahanidi@gmail.com | |
| Contact: Anteia Paraskeva | +306972868078 | aparask@med.uoa.gr |
| 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 | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2019 | ||||||||
| First Posted Date ICMJE | April 30, 2019 | ||||||||
| Last Update Posted Date | January 20, 2021 | ||||||||
| Actual Study Start Date ICMJE | May 22, 2019 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section | ||||||||
| Official Title ICMJE | The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | 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
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| Condition ICMJE | Hypotension | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
180 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2022 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Greece | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03931863 | ||||||||
| Other Study ID Numbers ICMJE | 124/17-04-2019 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Stavroula Karachanidi, Aretaieion University Hospital | ||||||||
| Study Sponsor ICMJE | Aretaieion University Hospital | ||||||||
| Collaborators ICMJE | University of Athens | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Aretaieion University Hospital | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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