Postdural Puncture HeadachePhase 4PDPH-N/VNCT07068230
Ondansetron and Dexamethasone for Prevention of PDPH, Nausea, and Vomiting
A Phase 4 study testing Ondansetron 8mg, Dexamethasone and Saline in people with Postdural Puncture Headache and Postoperative Nausea and Vomiting, run by Minia University at 1 site in Egypt.
Trial summary
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postdural Puncture Headache, Postoperative Nausea and Vomiting, Obstetric Anesthesia Problems
- What is being tested?
- Ondansetron 8mg, Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18 to 45 years
- Body Mass Index (BMI) between 23-27 kg/m²
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria
- Refusal to participate
- Conversion to general anesthesia due to failed spinal block
Show all 15Show fewer
- Known hypersensitivity to ondansetron or dexamethasone
- Contraindications to study medications, including:
- Diabetes mellitus
- Active infection
- Prolonged QT interval
- History of tobacco or drug use
- Coagulopathy or localized infection at the spinal injection site
- High-risk pregnancy (e.g., preeclampsia, placenta previa)
- History of chronic headache or migraine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section.
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.
Read the detailed description
This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia.
A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation.
All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in:
Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline),
Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL),
Group C (Control group) received 5 mL of 0.9% normal saline IV.
Study drugs were administered 5 minutes prior to the intrathecal injection. Blinding was maintained for patients, anesthesiologists, and outcome assessors.
PDPH was assessed for 7 days postoperatively. A standardized questionnaire and the Corbey scale were used to evaluate headache onset, severity, duration, and need for analgesics. Nausea and vomiting were assessed intraoperatively and postoperatively (up to 48 hours). Standard antiemetic rescue therapy was available as needed.
The protocol adhered to CONSORT guidelines and was approved by the Minia University Faculty of Medicine Research Ethics Committee. All participants provided written informed consent prior to enrollment.
This trial investigates whether prophylactic ondansetron or dexamethasone, individually, can significantly reduce PDPH and PONV compared to placebo. The results are expected to inform perioperative management and enhance maternal outcomes in cesarean section under spinal anesthesia.
- Conditions
- Postdural Puncture Headache, Postoperative Nausea and Vomiting, Obstetric Anesthesia Problems
- Being tested
- Ondansetron 8mg, Dexamethasone, Saline
- Keywords
- Ondansetron, Dexamethasone, Postdural Puncture Headache, Nausea, Vomiting
- Medical subject headings
- Post-Dural Puncture Headache, Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called zofran
Ondansetron 8 mg IV Administered 5 minutes before spinal anesthesia
DexamethasoneDrug
Dexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia
SalineDrug
Also called normal saline
5ml normal saline Administered 5 minutes before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron Group | Experimental | Participants in this group received 8 mg of intravenous ondansetron diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. Receives: Drug: Ondansetron 8mg |
| Dexamethasone Group | Experimental | Participants in this group received 8 mg of intravenous dexamethasone diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. Receives: Drug: Dexamethasone |
| Placebo Group | Experimental | Participants in this group received 5 mL of intravenous normal saline as placebo, administered 5 minutes before spinal anesthesia. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postdural Puncture Headache (PDPH)
The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist.
Measured: Up to 14 days postoperatively
Secondary outcomes (4)
Severity of PDPH
Severity of PDPH will be assessed using the Corbey Headache Severity Scale, which categorizes headache as:
Mild (no limitation of daily activity),
Moderate (some limitation of activity but no bed rest required), and
Severe (requires bed rest). Scale: Mild to Severe - higher levels indicate worse outcome
Measured: Up to 14 days postoperatively
Duration of PDPH
Duration (in days) from onset to resolution of PDPH symptoms in affected participants.
Measured: Up to 14 days postoperatively
Incidence of Nausea and Vomiting (N/V)
Incidence of intraoperative and postoperative nausea and vomiting, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = nausea and vomiting, 3 = repeated vomiting).
Measured: Intraoperatively and up to 4 days postoperatively
Neonatal Outcome (Apgar Score at 1 and 5 minutes)
Neonatal wellbeing will be assessed using the Apgar Score, a standardized clinical scale that evaluates Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration.
Scale Description:
Minimum Score: 0 (worst outcome)
Maximum Score: 10 (best outcome)
Higher scores reflect better neonatal condition
Measured: At 1 minute and 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- This study is a parallel assignment model in which 150 parturients undergoing elective cesarean section under spinal anesthesia were randomized into three groups in a 1:1:1 ratio to receive either intravenous ondansetron, dexamethasone, or placebo. Each participant was assigned to one intervention group and remained in that group for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mokhtar Mostafa Mahran Mohamed, Minia University
- Investigators
- mokhtar m mohamed, MD, Principal investigator, El-Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068230
- Sponsor's protocol ID
- EMUH-PDPH-2018-001
- Other IDs
- research ethical committee
- Acronym
- PDPH-N/V
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes will be made available upon reasonable request from qualified researchers for academic purposes. Data will be shared beginning 6 months after publication and available for up to 2 years.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section.
- ClinicalTrials.gov ID
- NCT07068230
- Acronym / sponsor ID
- PDPH-N/V / EMUH-PDPH-2018-001
- Conditions
- Postdural Puncture Headache, Postoperative Nausea and Vomiting, Obstetric Anesthesia Problems
- Keywords
- Ondansetron, Dexamethasone, Postdural Puncture Headache, Nausea, Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 16 Jul 2025 (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.
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.
Detailed description
This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia.
A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation.
All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in:
Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline),
Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL),
Group C (Control group) received 5 mL of 0.9% normal saline IV.
Study drugs were administered 5 minutes prior to the intrathecal injection. Blinding was maintained for patients, anesthesiologists, and outcome assessors.
PDPH was assessed for 7 days postoperatively. A standardized questionnaire and the Corbey scale were used to evaluate headache onset, severity, duration, and need for analgesics. Nausea and vomiting were assessed intraoperatively and postoperatively (up to 48 hours). Standard antiemetic rescue therapy was available as needed.
The protocol adhered to CONSORT guidelines and was approved by the Minia University Faculty of Medicine Research Ethics Committee. All participants provided written informed consent prior to enrollment.
This trial investigates whether prophylactic ondansetron or dexamethasone, individually, can significantly reduce PDPH and PONV compared to placebo. The results are expected to inform perioperative management and enhance maternal outcomes in cesarean section under spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- This study is a parallel assignment model in which 150 parturients undergoing elective cesarean section under spinal anesthesia were randomized into three groups in a 1:1:1 ratio to receive either intravenous ondansetron, dexamethasone, or placebo. Each participant was assigned to one intervention group and remained in that group for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Group | Experimental | Drug: Ondansetron 8mgParticipants in this group received 8 mg of intravenous ondansetron diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. |
| Dexamethasone Group | Experimental | Drug: DexamethasoneParticipants in this group received 8 mg of intravenous dexamethasone diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. |
| Placebo Group | Experimental | Drug: SalineParticipants in this group received 5 mL of intravenous normal saline as placebo, administered 5 minutes before spinal anesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Female patients aged 18 to 45 years
- Body Mass Index (BMI) between 23-27 kg/m²
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria
- Refusal to participate
Key exclusion criteria (0 listed)
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 8mgAlso: zofranOndansetron 8 mg IV Administered 5 minutes before spinal anesthesia | Drug | Ondansetron Group |
| DexamethasoneDexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia | Drug | Dexamethasone Group |
| SalineAlso: normal saline5ml normal saline Administered 5 minutes before spinal anesthesia | Drug | Placebo Group |
Primary outcome
Incidence of Postdural Puncture Headache (PDPH)
Time frame: Up to 14 days postoperatively
The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist.
4 secondary outcomes
Severity of PDPH
Time frame: Up to 14 days postoperatively
Duration of PDPH
Time frame: Up to 14 days postoperatively
Incidence of Nausea and Vomiting (N/V)
Time frame: Intraoperatively and up to 4 days postoperatively
Neonatal Outcome (Apgar Score at 1 and 5 minutes)
Time frame: At 1 minute and 5 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes will be made available upon reasonable request from qualified researchers for academic purposes. Data will be shared beginning 6 months after publication and available for up to 2 years.
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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. This study is not recruiting at the moment.
mokhtar m mohamed, MD principal investigator
El-Minia University Hospital
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 8mg, Dexamethasone and Saline in people with Postdural Puncture Headache and Postoperative Nausea and Vomiting, run by Minia University at 1 site in Egypt.
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 15 inclusion and 0 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postdural Puncture Headache (PDPH) (time frame: Up to 14 days postoperatively). 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 18 Jul 2025.