Intraoperative Nausea-retching-vomiting EpisodesPhase 4NCT07740577
Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
A Phase 4 study testing Ondansetron 4mg and metoclopramide in people with Intraoperative Nausea-retching-vomiting Episodes and Spinal Aneshtesia, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective randomized double-blind study is to compare the effectiveness of routine antiemetic prophylaxis for the prevention of intraoperative nausea and vomiting (IONV) in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia, Ceserean Section
- What is being tested?
- Ondansetron 4mg and metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2026to 2 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women scheduled for emergency cesarean delivery under spinal anesthesia
- Non-fasted (full-stomach) parturients
- American Society of Anesthesiologists (ASA) physical status I-II
- Age ≥ 18 years
- Singleton pregnancy
- Ability to provide written informed consent
Who cannot join
- ASA physical status III or higher
- Refusal to participate
- Elective cesarean delivery (non-emergency cases)
- Preoperative antiemetic use within 24 hours before surgery
- Known allergy or contraindication to study drugs (ondansetron or metoclopramide)
- Pre-existing gastrointestinal disorders (e.g., severe GERD, gastroparesis, bowel obstruction)
Show all 12Show fewer
- Psychiatric illness or current use of psychotropic medications
- Preoperative anemia (as defined by institutional threshold, e.g., Hb < 10 g/dL)
- Intraoperative conversion to general anesthesia
- Massive intraoperative hemorrhage (>1000-1500 mL or requiring transfusion, depending on your protocol definition)
- Intraoperative administration of additional sedative or antiemetic agents outside study protocol
- Multiple gestation pregnancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa, Eyyübiye, 63040
Tolga Karaçay, 05458718351, tkaracay35@gmail.com
Servet Sürmeli, M.D.
About this study
Official title: Comparative Effectiveness of Routine Antiemetic Prophylaxis in Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia: A Prospective Randomized Controlled Trial
The aim of this prospective randomized double-blind study is to compare the effectiveness of routine antiemetic prophylaxis for the prevention of intraoperative nausea and vomiting (IONV) in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Nausea and vomiting are common complications during cesarean delivery performed under spinal anesthesia and may negatively affect maternal comfort and perioperative safety. The incidence of these symptoms may be particularly increased in emergency cesarean sections involving non-fasted (full-stomach) parturients. This study compares two commonly used antiemetic strategies, namely 5-hydroxytryptamine-3 (5-HT3) receptor antagonists and dopamine receptor antagonists, to determine their relative effectiveness in preventing IONV during surgery.
The findings are expected to contribute to optimization of antiemetic prophylaxis protocols, improvement of maternal comfort, and reduction of perioperative complications associated with nausea and vomiting during emergency cesarean delivery.
Read the detailed description
This prospective, randomized, double-blind clinical trial is designed to evaluate the comparative effectiveness of routine antiemetic prophylaxis for preventing intraoperative nausea and vomiting in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Eligible participants will be pregnant women with American Society of Anesthesiologists (ASA) physical status I-II who undergo emergency cesarean delivery under spinal anesthesia. Only non-fasted (full-stomach) parturients will be included.
Exclusion criteria include ASA physical status III or higher, preoperative anemia, massive intraoperative hemorrhage, requirement for additional intraoperative hypnotic agents, known gastrointestinal disease, psychiatric disorders or psychotropic medication use, and administration of antiemetic medication within 24 hours before surgery.
Participants will be randomized using a sealed-envelope allocation method before arrival in the operating room. Before transfer to the operating room, patients will receive the assigned study medication according to the randomization protocol. Both patients and the attending anesthesiologist responsible for outcome assessment will remain blinded to group allocation.
Participants will receive one of the following prophylactic antiemetic regimens:
Group O: 5-HT3 receptor antagonist (e.g., ondansetron or equivalent agent) Group M: Dopamine receptor antagonist (e.g., metoclopramide)
Standard monitoring will include electrocardiography, non-invasive blood pressure measurement, and peripheral oxygen saturation (SpO₂). Following intravenous cannulation, Ringer's lactate infusion will be initiated.
Spinal anesthesia will be performed at the L4-L5 interspace using 10 mg hyperbaric bupivacaine. After block placement, patients will be positioned supine with left uterine displacement to minimize aortocaval compression. Supplemental oxygen will be administered via nasal cannula at 2 L/min.
All participants will receive prophylactic intravenous ephedrine 5 mg. Additional 5 mg boluses will be administered if systolic blood pressure decreases below 100 mmHg or more than 20% from baseline values. Intravenous atropine 0.5 mg will be administered in cases of bradycardia (heart rate below 50-60 beats/min).
Following delivery of the fetal shoulders, oxytocin 20 IU will be administered intravenously as an infusion.
Demographic and perioperative data including age, body mass index, fasting duration since last solid food intake, smoking status, and operative duration will be recorded.
Hemodynamic variables (blood pressure and heart rate) will be recorded every 2 minutes until delivery and every 5 minutes thereafter until completion of surgery.
Intraoperative nausea and vomiting will be assessed during three predefined periods:
From 5 minutes after spinal anesthesia until delivery During and immediately after delivery From delivery until skin closure
Severity of nausea and vomiting will be evaluated using the Bellville scoring system:
0 = No nausea
- = Nausea
- = Retching (gagging)
- = Vomiting
Primary Outcome
Incidence of intraoperative nausea and vomiting occurring during and immediately after delivery.
Secondary Outcomes
Incidence and severity of intraoperative nausea and vomiting during the other predefined assessment periods.
Postoperative complications associated with antiemetic therapy
- Conditions
- Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia, Ceserean Section, Antiemetic Therapy, Ondansetron, Metoclopramide
- Being tested
- Ondansetron 4mg, metoclopramide
- Keywords
- Cesarean Section, Emergency Cesarean Delivery, Non-fasted Parturients, Full Stomach, Spinal Anesthesia, Antiemetic Prophylaxis, Intraoperative Nausea and Vomiting, Obstetric Anesthesia, Maternal Outcomes
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4mgDrug
Prophylactic intravenous administration of a 5-HT3 receptor antagonist prior to cesarean delivery under spinal anesthesia.
metoclopramideDrug
Prophylactic intravenous administration of a dopamine receptor antagonist prior to cesarean delivery under spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 5-HT3 Receptor Antagonist Group | Experimental | Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a 5-HT3 receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed. Receives: Drug: Ondansetron 4mg |
| Dopamine Receptor Antagonist Group | Experimental | Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a dopamine receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed. Receives: Drug: metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
Incidence of nausea, retching, or vomiting occurring during the immediate period following fetal delivery, assessed using the Bellville scoring system. From fetal delivery until uterine closure.
Measured: Perioperative
Secondary outcomes (4)
Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery
Incidence of nausea, retching, or vomiting occurring from initiation of spinal anesthesia until fetal delivery.From spinal anesthesia administration until fetal delivery.
Measured: Perioperative
Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery
Incidence of nausea, retching, or vomiting occurring in the late intraoperative period immediately preceding fetal delivery. From uterine incision to fetal delivery
Measured: Perioperative
Incidence of Intraoperative Nausea and Vomiting During Skin Closure
Incidence of nausea, retching, or vomiting occurring during surgical skin closure.
Measured: Perioperative
Postoperative Complications Related to Antiemetic Prophylaxis
Incidence of adverse effects associated with prophylactic antiemetic agents including headache, dizziness, hypotension, extrapyramidal symptoms, or sedation. From end of surgery through 24 hours postoperatively.
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start30 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Nausea-retching-vomiting EpisodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving routine prophylactic antiemetic treatment before emergency cesarean delivery under spinal anesthesia. One group will receive a 5-HT3 receptor antagonist, whereas the other group will receive a dopamine receptor antagonist. Outcomes will be compared between groups during the intraoperative and early postoperative periods.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tolga Karaçay, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740577
- Sponsor's protocol ID
- HRÜ/26.07.15
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Routine Antiemetic Prophylaxis in Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07740577
- Acronym / sponsor ID
- HRÜ/26.07.15
- Conditions
- Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia, Ceserean Section, Antiemetic Therapy, Ondansetron, Metoclopramide
- Keywords
- Cesarean Section, Emergency Cesarean Delivery, Non-fasted Parturients, Full Stomach, Spinal Anesthesia, Antiemetic Prophylaxis, Intraoperative Nausea and Vomiting, Obstetric Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective randomized double-blind study is to compare the effectiveness of routine antiemetic prophylaxis for the prevention of intraoperative nausea and vomiting (IONV) in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Nausea and vomiting are common complications during cesarean delivery performed under spinal anesthesia and may negatively affect maternal comfort and perioperative safety. The incidence of these symptoms may be particularly increased in emergency cesarean sections involving non-fasted (full-stomach) parturients. This study compares two commonly used antiemetic strategies, namely 5-hydroxytryptamine-3 (5-HT3) receptor antagonists and dopamine receptor antagonists, to determine their relative effectiveness in preventing IONV during surgery.
The findings are expected to contribute to optimization of antiemetic prophylaxis protocols, improvement of maternal comfort, and reduction of perioperative complications associated with nausea and vomiting during emergency cesarean delivery.
Detailed description
This prospective, randomized, double-blind clinical trial is designed to evaluate the comparative effectiveness of routine antiemetic prophylaxis for preventing intraoperative nausea and vomiting in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.
Eligible participants will be pregnant women with American Society of Anesthesiologists (ASA) physical status I-II who undergo emergency cesarean delivery under spinal anesthesia. Only non-fasted (full-stomach) parturients will be included.
Exclusion criteria include ASA physical status III or higher, preoperative anemia, massive intraoperative hemorrhage, requirement for additional intraoperative hypnotic agents, known gastrointestinal disease, psychiatric disorders or psychotropic medication use, and administration of antiemetic medication within 24 hours before surgery.
Participants will be randomized using a sealed-envelope allocation method before arrival in the operating room. Before transfer to the operating room, patients will receive the assigned study medication according to the randomization protocol. Both patients and the attending anesthesiologist responsible for outcome assessment will remain blinded to group allocation.
Participants will receive one of the following prophylactic antiemetic regimens:
Group O: 5-HT3 receptor antagonist (e.g., ondansetron or equivalent agent) Group M: Dopamine receptor antagonist (e.g., metoclopramide)
Standard monitoring will include electrocardiography, non-invasive blood pressure measurement, and peripheral oxygen saturation (SpO₂). Following intravenous cannulation, Ringer's lactate infusion will be initiated.
Spinal anesthesia will be performed at the L4-L5 interspace using 10 mg hyperbaric bupivacaine. After block placement, patients will be positioned supine with left uterine displacement to minimize aortocaval compression. Supplemental oxygen will be administered via nasal cannula at 2 L/min.
All participants will receive prophylactic intravenous ephedrine 5 mg. Additional 5 mg boluses will be administered if systolic blood pressure decreases below 100 mmHg or more than 20% from baseline values. Intravenous atropine 0.5 mg will be administered in cases of bradycardia (heart rate below 50-60 beats/min).
Following delivery of the fetal shoulders, oxytocin 20 IU will be administered intravenously as an infusion.
Demographic and perioperative data including age, body mass index, fasting duration since last solid food intake, smoking status, and operative duration will be recorded.
Hemodynamic variables (blood pressure and heart rate) will be recorded every 2 minutes until delivery and every 5 minutes thereafter until completion of surgery.
Intraoperative nausea and vomiting will be assessed during three predefined periods:
From 5 minutes after spinal anesthesia until delivery During and immediately after delivery From delivery until skin closure
Severity of nausea and vomiting will be evaluated using the Bellville scoring system:
0 = No nausea
- = Nausea
- = Retching (gagging)
- = Vomiting
Primary Outcome
Incidence of intraoperative nausea and vomiting occurring during and immediately after delivery.
Secondary Outcomes
Incidence and severity of intraoperative nausea and vomiting during the other predefined assessment periods.
Postoperative complications associated with antiemetic therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving routine prophylactic antiemetic treatment before emergency cesarean delivery under spinal anesthesia. One group will receive a 5-HT3 receptor antagonist, whereas the other group will receive a dopamine receptor antagonist. Outcomes will be compared between groups during the intraoperative and early postoperative periods.
| Arm | Type | Receives |
|---|---|---|
| 5-HT3 Receptor Antagonist Group | Experimental | Drug: Ondansetron 4mgParticipants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a 5-HT3 receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed. |
| Dopamine Receptor Antagonist Group | Experimental | Drug: metoclopramideParticipants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a dopamine receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women scheduled for emergency cesarean delivery under spinal anesthesia
- Non-fasted (full-stomach) parturients
- American Society of Anesthesiologists (ASA) physical status I-II
- Age ≥ 18 years
- Singleton pregnancy
Key exclusion criteria (12 listed)
- ASA physical status III or higher
- Refusal to participate
- Elective cesarean delivery (non-emergency cases)
- Preoperative antiemetic use within 24 hours before surgery
- Known allergy or contraindication to study drugs (ondansetron or metoclopramide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 4mgProphylactic intravenous administration of a 5-HT3 receptor antagonist prior to cesarean delivery under spinal anesthesia. | Drug | 5-HT3 Receptor Antagonist Group |
| metoclopramideProphylactic intravenous administration of a dopamine receptor antagonist prior to cesarean delivery under spinal anesthesia. | Drug | Dopamine Receptor Antagonist Group |
Primary outcome
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
Time frame: Perioperative
Incidence of nausea, retching, or vomiting occurring during the immediate period following fetal delivery, assessed using the Bellville scoring system. From fetal delivery until uterine closure.
4 secondary outcomes
Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery
Time frame: Perioperative
Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery
Time frame: Perioperative
Incidence of Intraoperative Nausea and Vomiting During Skin Closure
Time frame: Perioperative
Postoperative Complications Related to Antiemetic Prophylaxis
Time frame: Postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 4mg and metoclopramide in people with Intraoperative Nausea-retching-vomiting Episodes and Spinal Aneshtesia, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tolga Karaçay (+905458718351, tkaracay35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.