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The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery.
The main questions it aims to answer are:
Does intravenous dexamethasone reduce the incidence of post-spinal hypotension?
Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)?
Does intravenous dexamethasone prolong the duration of postoperative analgesia?
Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief.
Participants will:
Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia.
Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery).
Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale).
Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-Spinal Hypotension | The number of participants experiencing at least one episode of post-spinal hypotension. Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value. Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%. Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit | From the induction of spinal anesthesia until the completion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting (PONV) | The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment. Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg. | From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ho Chi Minh City (UMC) - Campus 2 | Ho Chi Minh City | Ho Chi Minh | 700000 | Vietnam |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Prospective, randomized, placebo-controlled, single-blind, parallel-group clinical trial
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| Placebo | Other | Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia. |
|
| Duration of Postoperative Analgesia | The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication. Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10). | From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours) |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |