Condition or disease | Intervention/treatment | Phase |
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Spinal Anesthetics Causing Adverse Effects in Therapeutic Use | Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section |
Estimated Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | December 1, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Dexamethasone |
Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
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 |
Active Comparator: Cyclizine |
Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
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 |
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.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mina Habib, Principal Investigator | +201092644868 | micheale14@gmail.com |
Tracking Information | |||||
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First Submitted Date ICMJE | March 26, 2019 | ||||
First Posted Date ICMJE | April 30, 2019 | ||||
Last Update Posted Date | April 30, 2019 | ||||
Estimated Study Start Date ICMJE | September 1, 2019 | ||||
Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Change in postoperative pain (assessed by VAS ). [ Time Frame: Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours ] 0 meaning no pain at all, and 10 described as the worst pain experienced.
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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 | Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section | ||||
Official Title ICMJE | Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section | ||||
Brief Summary | 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: A) Patient related risk factors:
B) Anesthesia related risk factors:
Anti-emetic drugs used to treat PONV:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Spinal Anesthetics Causing Adverse Effects in Therapeutic Use | ||||
Intervention ICMJE | Drug: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
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 |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* 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 | Unknown status | ||||
Estimated Enrollment ICMJE |
160 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2020 | ||||
Estimated Primary Completion Date | October 31, 2020 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03931135 | ||||
Other Study ID Numbers ICMJE | Cyclizine vs dexa for PONV | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mina Elia Azmy Habib, Assiut University | ||||
Study Sponsor ICMJE | Assiut University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Assiut University | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |