Spinal Anesthetics Causing Adverse Effects in Therapeutic UseNCT03931135
Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section
A study testing IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section in people with Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Assiut University.
Trial summary
Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2020
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 18 to 45 years old
- Parturient
- ASA I-II
- Full Term
Who cannot join
- Women who has obstetric complications.
- Women with evidence of foetal compromise.
- Patients who have gastro-intestinal diseases.
- Administration of anti-emetic drugs within 24 hours before operation.
- Patients who have hyperemesis gravidarium
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section
Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate.
Read the detailed description
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in patients. PONV is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, PONV is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with PONV are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.
There are many well-established risk factors for PONV which are classified in two classes:
- Patient related risk factors:
- Female gender is consistently the strongest risk factor for PONV, female patient are three times more likely than men to suffer from PONV.
- For adult patient, age is a statistically, though not clinically, relevant risk factor, with the incidence of PONV decreasing as patients age. For pediatric patients, however, age increases the risk of post-operative vomiting (POV), such that children older than 3 years have been shown to have an increased risk of POV compared with children younger than 3 years.
- Obesity is a strong risk factor for PONV: patients with body mass index (BMI) more than 30 have the double risk of PONV.
- Non-smoking status roughly doubles the patient's risk of PONV. The specific mechanism underlying smoking's protective effect is unknown ,but one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of emetogenic volatile anesthetics.
- History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer increases the risk for PONV.
- History of motion sickness, Meniere's disease or previous PONV indicates a general susceptibility to PONV.
- Anesthesia related risk factors:
- The use of volatile anesthetics is associated with a two-fold increase in the risk of PONV, with risk increasing in a dose dependent manner.
- Intraoperative and postoperative opioid use increases the risk of PONV in a dose dependent manner by the mechanism of reducing muscle tone and peristaltic activity, thereby delaying gastric emptying, inducing distention, and triggering the vomiting reflex.
- The duration of anesthesia can help predict the patient's risk of PONV, since the duration of anesthesia describes the patient's exposure to emetogenic stimuli like volatile anesthetics and intraoperative opioids.
Anti-emetic drugs used to treat PONV:
- The first line is classified into three classes: serotonin antagonists (e.g. ondansetron), corticosteroids (e.g. dexamethasone), and dopamine antagonists (e.g. droperidol) have similar efficacy against PONV, with a relative risk reduction of about 25%. Moreover, they act independently and when used in combination, have additiveeffects. Dexamethasone : it can be effective in preventing PONV in adults and children. Compared with other operative medications, dexamethasone has equal or even better efficacy in reducing the incidence of PONV and has the advantages of low cost and longer effectiveness as well. The mechanism of the antiemetic action of dexamethasone is still not clearly known. Glucocorticoids receptors are found in nucleus of the solitary tract, the raphe nucleus and the area postrema and all are associated with regulating nausea and vomiting. Dexamethasone may affect PONV by modulating neurotransmission or receptor density in these nuclei. Clinically, dexamethasone as a preventive drug against PONV has not caused fatal outcome; therefore, it is generally considered to be an effective and safe anti-emetic. Nevertheless, its use in this regard may lead to adverse effects, principally postoperative hyperglycemia and infection.
- The second line is Cyclizine: a histamine H1 antagonist given by mouth or parenterally for control of postoperative and drug-induced nausea and vomiting and in motion sickness. additionally, it has been used in management of vertigo in diseases affecting the vestibular apparatus. Although the mechanism by which cyclizine exerts its antiemetic and antivertigo effects has not been fully elucidated, its central anticholinergic properties are partially responsible. It also possesses anticholinergic, antihistaminic, central nervous system depressant and local anesthetic effects. cyclizine is metabolized to its N-demethylated derivative , norcyclizine , which has little antihistaminic activity compared to cyclizine.
- Being tested
- IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean sectionDrug
The first group (Dexamethasone) will receive 8 mg IV dexamethasone within 1-2 minutes after the umbilical cord is clamped.
The second group (Cyclizine) will receive 50 mg cyclizine within 1-2 minutes after the umbilical cord is clamped
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Not described Receives: Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section |
| Cyclizine | Active comparator | Not described Receives: Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
Nausea and vomiting were recorded as present or absent,
All measurements and ratings were completed at the time when patients rated their PONV intensity.
We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.
Measured: Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention
Secondary outcomes (1)
Change in postoperative pain (assessed by VAS ).
0 meaning no pain at all, and 10 described as the worst pain experienced.
Measured: Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Elia Azmy Habib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931135
- Sponsor's protocol ID
- Cyclizine vs dexa for PONV
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT03931135
- Acronym / sponsor ID
- Cyclizine vs dexa for PONV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Apr 2019 (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.
Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate.
Detailed description
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in patients. PONV is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, PONV is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with PONV are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.
There are many well-established risk factors for PONV which are classified in two classes:
- Patient related risk factors:
- Female gender is consistently the strongest risk factor for PONV, female patient are three times more likely than men to suffer from PONV.
- For adult patient, age is a statistically, though not clinically, relevant risk factor, with the incidence of PONV decreasing as patients age. For pediatric patients, however, age increases the risk of post-operative vomiting (POV), such that children older than 3 years have been shown to have an increased risk of POV compared with children younger than 3 years.
- Obesity is a strong risk factor for PONV: patients with body mass index (BMI) more than 30 have the double risk of PONV.
- Non-smoking status roughly doubles the patient's risk of PONV. The specific mechanism underlying smoking's protective effect is unknown ,but one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of emetogenic volatile anesthetics.
- History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer increases the risk for PONV.
- History of motion sickness, Meniere's disease or previous PONV indicates a general susceptibility to PONV.
- Anesthesia related risk factors:
- The use of volatile anesthetics is associated with a two-fold increase in the risk of PONV, with risk increasing in a dose dependent manner.
- Intraoperative and postoperative opioid use increases the risk of PONV in a dose dependent manner by the mechanism of reducing muscle tone and peristaltic activity, thereby delaying gastric emptying, inducing distention, and triggering the vomiting reflex.
- The duration of anesthesia can help predict the patient's risk of PONV, since the duration of anesthesia describes the patient's exposure to emetogenic stimuli like volatile anesthetics and intraoperative opioids.
Anti-emetic drugs used to treat PONV:
- The first line is classified into three classes: serotonin antagonists (e.g. ondansetron), corticosteroids (e.g. dexamethasone), and dopamine antagonists (e.g. droperidol) have similar efficacy against PONV, with a relative risk reduction of about 25%. Moreover, they act independently and when used in combination, have additiveeffects. Dexamethasone : it can be effective in preventing PONV in adults and children. Compared with other operative medications, dexamethasone has equal or even better efficacy in reducing the incidence of PONV and has the advantages of low cost and longer effectiveness as well. The mechanism of the antiemetic action of dexamethasone is still not clearly known. Glucocorticoids receptors are found in nucleus of the solitary tract, the raphe nucleus and the area postrema and all are associated with regulating nausea and vomiting. Dexamethasone may affect PONV by modulating neurotransmission or receptor density in these nuclei. Clinically, dexamethasone as a preventive drug against PONV has not caused fatal outcome; therefore, it is generally considered to be an effective and safe anti-emetic. Nevertheless, its use in this regard may lead to adverse effects, principally postoperative hyperglycemia and infection.
- The second line is Cyclizine: a histamine H1 antagonist given by mouth or parenterally for control of postoperative and drug-induced nausea and vomiting and in motion sickness. additionally, it has been used in management of vertigo in diseases affecting the vestibular apparatus. Although the mechanism by which cyclizine exerts its antiemetic and antivertigo effects has not been fully elucidated, its central anticholinergic properties are partially responsible. It also possesses anticholinergic, antihistaminic, central nervous system depressant and local anesthetic effects. cyclizine is metabolized to its N-demethylated derivative , norcyclizine , which has little antihistaminic activity compared to cyclizine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section |
| Cyclizine | Active comparator | Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- 18 to 45 years old
- Parturient
- ASA I-II
- Full Term
Key exclusion criteria (5 listed)
- Women who has obstetric complications.
- Women with evidence of foetal compromise.
- Patients who have gastro-intestinal diseases.
- Administration of anti-emetic drugs within 24 hours before operation.
- Patients who have hyperemesis gravidarium
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 |
|---|---|---|
| IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean sectionThe first group (Dexamethasone) will receive 8 mg IV dexamethasone within 1-2 minutes after the umbilical cord is clamped. The second group (Cyclizine) will receive 50 mg cyclizine within 1-2 minutes after the umbilical cord is clamped | Drug | Cyclizine, Dexamethasone |
Primary outcome
Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
Time frame: Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention
Nausea and vomiting were recorded as present or absent, All measurements and ratings were completed at the time when patients rated their PONV intensity. We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.
1 secondary outcome
Change in postoperative pain (assessed by VAS ).
Time frame: Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section in people with Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Assiut 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 5 inclusion and 5 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 30 Apr 2019. 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 Mina Habib, Principal Investigator (+201092644868, micheale14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale. (time frame: Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention). 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 30 Apr 2019.