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The goal of this clinical trial is to learn if drug ondansetron, used in lingual form, lowers the incidence of spinal anesthesia-induced hypotension in cesarean sections. It will also learn about the safety of drug ondansetron. The main questions it aims to answer are
Does the drug ondansetron, used in lingual form, lower the incidence of spinal anesthesia-induced hypotension in cesarean sections? What medical problems do participants have when taking the drug ondansetron? Researchers will compare drug ondansetron to a placebo (a look-alike substance that contains no drug) to see if drug ondansetron works to reduce the incidence of spinal anesthesia-induced hypotension in cesarean sections
Participants will:
Take drug ondansetron or a placebo before induction of spinal anesthesia
Spinal anesthesia, which is extensively used in a variety of surgical operations, frequently causes hypotension due to sympathetic nerve blocking. This reduction in blood pressure might have negative consequences, especially in people with cardiovascular comorbidities. Ondansetron, a selective serotonin 5-HT3 receptor antagonist, is well known for its antiemetic effects. However, its ability to reduce hypotension during spinal anesthesia has sparked great interest in recent years. Thus, it regulates cardiovascular function, vasodilation, and vascular tone and helps to maintain a more steady hemodynamic profile during spinal anesthesia.
A growing amount of evidence supports the use of ondansetron as a preventive strategy against spinal anesthesia-induced hypotension. This technique not only improves patient safety but also minimizes intraoperative problems. As research advances, using ondansetron in anesthetic protocols may become commonplace, reflecting its numerous benefits in the perioperative situation.
Objective: To investigate the efficacy of the lingual film form of ondansetron after use in parturients undergoing spinal anesthesia during cesarean delivery to reduce total ephedrine consumption and spinal-induced hypotension.
Methodology: Following the administrative ethical committee approval and informed patient consent obtained from 112 patients undergoing cesarean delivery in Suez Canal University Hospital, they will be randomly assigned to one of the two groups using a computer software program.
Group A (56 patients) will be administered 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia.
Group B (56 patients) will be administered a placebo lingual film form 15 minutes before spinal anesthesia.
Expected outcome: The investigators can expect a reduction in the total ephedrine consumption and more cardiovascular stability based on the previous trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ondansetron | Active Comparator | 8 mg of the lingual film form of ondansetron will be given 15 minutes before spinal anesthesia |
|
| placebo | Placebo Comparator | a placebo lingual film form will be given 15 minutes before spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ondansetron lingual film | Drug | 8 mg of the lingual film form of ondansetron, given 15 minutes before spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| ephidrine consumption | To evaluate the impact of lingual ondansetron on parturients having cesarean sections' overall intraoperative ephedrine consumption | From the moment the surgery starts until it is finished, or after 90 minutes has passed, whichever is longer |
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Inclusion Criteria:
Exclusion Criteria:
only females undergoing ceserean sections
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrhman Alshawadfy | Faculty of Medicine, Suez Canal University Ismailia, , Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Suez Canal University | Ismailia | Egypt |
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| Placebo | Drug | a placebo lingual film form, given 15 minutes before spinal anesthesia |
|