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The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia. |
|
| Ondansetron 4 mg | Experimental | A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia. |
|
| Ondansetron 8 mg | Experimental | A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Drug | A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall stability of systolic blood pressure control versus baseline | Evaluated by performance error (PE) | 1-15 minutes after spinal anesthesia |
| The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-15 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Overall stability of heart rate control versus baseline | Evaluated by performance error (PE). | 1-15 minutes after spinal anesthesia |
| The incidence of severe post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 60% of the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Chen, M.D. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | 750004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40248081 | Derived | Qin R, Xu X, Zhao N, Shi Y, Chen Y, Chen J, Ni X. Effect of different prophylactical doses of ondansetron for the hemodynamic stability in patients undergoing cesarean section: a randomized controlled study. Front Med (Lausanne). 2025 Apr 3;12:1495721. doi: 10.3389/fmed.2025.1495721. eCollection 2025. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D017294 | Ondansetron |
| D058831 | Serotonin 5-HT3 Receptor Antagonists |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ondansetron 4 mg | Drug | A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia. |
|
|
| Ondansetron 8 mg | Drug | A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia. |
|
|
| 1-15 minutes after spinal anesthesia |
| The incidence of nausea and vomiting. | Presence of nausea and vomiting in patients after spinal anesthesia | 1-15 minutes after spinal anesthesia |
| The incidence of bradycardia. | Heart rate < 55 beats/min. | 1-15 minutes after spinal anesthesia |
| The incidence of hypertension | Systolic blood pressure (SBP) >120% of the baseline. | 1-15 minutes after spinal anesthesia |
| pH | From umbilical arterial blood gases. | Immediately after delivery |
| Partial pressure of oxygen | From umbilical arterial blood gases. | Immediately after delivery |
| Base excess | From umbilical arterial blood gases. | Immediately after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 min after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 min after delivery |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D012702 | Serotonin Antagonists |
| D018490 | Serotonin Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |