Emetic Attacks During Caesarean Delivery With Spinal AnesthesiaNCT06300346
Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery
A study testing Propofol in people with Emetic Attacks During Caesarean Delivery With Spinal Anesthesia, run by Sohag University.
Trial summary
Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emetic Attacks During Caesarean Delivery With Spinal Anesthesia
- What is being tested?
- Propofol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 18 Aug 2024
- Phase
- Interventional
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21-40 years old.
- Physical status American Society of Anesthesiologists (ASA)I\&II.
- Body mass index (BMI) < 35\&>20 kg/m2.
- Elective uncomplicated cesarean section under spinal anesthesia.
Who cannot join
- Patient refusal.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal and respiratory diseases.
- Psychological and mental disorders.
- Patient with reduced level of consciousness.
- Hypertensive, cardiac, and diabetic patients.
- Patients receiving anticoagulants therapy or suspected coagulopathy.
Trial locations and contacts
No sites are listed yet.
Ahmed M Abd-Elmaboud, assistant professor contact
About this study
Official title: Comparison Between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks During Caesarean Delivery With Spinal Anesthesia: Randomized Clinical Trial
Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.
Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Pregabalin
Ondansetron
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | 30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture. Receives: Drug: Propofol |
| pregabalin | Active comparator | 30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision. Receives: Drug: Propofol |
| ondansetron | Active comparator | 30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nausea and vomiting with spinal anesthesia
To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.
Measured: 5 months
Secondary outcomes (1)
Measurement of hemodynamics postoperative
Measurement of hemodynamics postoperative and Incidence of other side effects as :hypotension measured by non invasive blood pressure monitoring
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion18 Aug 2024 (estimated)
- Study completion18 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Emetic Attacks During Caesarean Delivery With Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtehal Ahmed Abdellattif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300346
- Sponsor's protocol ID
- Soh-Med-23-12-02MS
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hirmanpour A, Safavi M, Honarmand A, Hosseini AZ, Sepehrian M. The comparative study of intravenous Ondansetron and sub-hypnotic Propofol dose in control and treatment of intrathecal Sufentanil-induced pruritus in elective caesarean surgery. J Res Pharm Pract. 2015 Apr-Jun;4(2):57-63. doi: 10.4103/2279-042X.155751.
PubMed 25984542Mokini Z, Genocchio V, Forget P, Petrini F. Metoclopramide and Propofol to Prevent Nausea and Vomiting during Cesarean Section under Spinal Anesthesia: A Randomized, Placebo-Controlled, Double-Blind Trial. J Clin Med. 2021 Dec 26;11(1):110. doi: 10.3390/jcm11010110.
PubMed 35011852Athavale A, Athavale T, Roberts DM. Antiemetic drugs: what to prescribe and when. Aust Prescr. 2020 Apr;43(2):49-56. doi: 10.18773/austprescr.2020.011. Epub 2020 Apr 1.
PubMed 32346211Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.
PubMed 32913634
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks During Caesarean Delivery With Spinal Anesthesia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06300346
- Acronym / sponsor ID
- Soh-Med-23-12-02MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 18 Aug 2024 (estimated)
- Study completion
- 18 Aug 2024 (estimated)
- First posted
- 8 Mar 2024 (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.
Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.
Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: Propofol30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture. |
| pregabalin | Active comparator | Drug: Propofol30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision. |
| ondansetron | Active comparator | Drug: Propofol30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 21-40 years old.
- Physical status American Society of Anesthesiologists (ASA)I\&II.
- Body mass index (BMI) < 35\&>20 kg/m2.
- Elective uncomplicated cesarean section under spinal anesthesia.
Key exclusion criteria (7 listed)
- Patient refusal.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal and respiratory diseases.
- Psychological and mental disorders.
- Patient with reduced level of consciousness.
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 |
|---|---|---|
| PropofolAlso: PregabalinOndansetron | Drug | ondansetron, pregabalin, propofol |
Primary outcome
Incidence of nausea and vomiting with spinal anesthesia
Time frame: 5 months
To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.
1 secondary outcome
Measurement of hemodynamics postoperative
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 25984542Hirmanpour A, Safavi M, Honarmand A, Hosseini AZ, Sepehrian M. The comparative study of intravenous Ondansetron and sub-hypnotic Propofol dose in control and treatment of intrathecal Sufentanil-induced pruritus in elective caesarean surgery. J Res Pharm Pract. 2015 Apr-Jun;4(2):57-63. doi: 10.4103/2279-042X.155751.
- Background: PubMed 35011852Mokini Z, Genocchio V, Forget P, Petrini F. Metoclopramide and Propofol to Prevent Nausea and Vomiting during Cesarean Section under Spinal Anesthesia: A Randomized, Placebo-Controlled, Double-Blind Trial. J Clin Med. 2021 Dec 26;11(1):110. doi: 10.3390/jcm11010110.
- Background: PubMed 32346211Athavale A, Athavale T, Roberts DM. Antiemetic drugs: what to prescribe and when. Aust Prescr. 2020 Apr;43(2):49-56. doi: 10.18773/austprescr.2020.011. Epub 2020 Apr 1.
- Background: PubMed 32913634Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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.
Ahmed M Abd-Elmaboud, assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Emetic Attacks During Caesarean Delivery With Spinal Anesthesia, run by Sohag University.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtihal A Abd-Ellateef, resident (01119925603, ebtehalahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nausea and vomiting with spinal anesthesia (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300346, which also lists 4 linked publications.
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 8 Mar 2024.