Hypotension During Cesarean Delivery, Pain, Postoperative, Postoperative Nausea and Vomiting (PONV)
Conditions
Keywords
Dexamethasone, Prophylaxis, Elective Cesarean Delivery, Spinal-induced Hypotension, Postoperative Analgesia, Parturients
Brief summary
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.
Interventions
DRUGDexamethasone
Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
OTHERPlacebo
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.
Sponsors
University Medical Center Ho Chi Minh City (UMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomized, placebo-controlled, single-blind, parallel-group clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Singleton pregnancy * Gestational age ≥ 37 weeks * American Society of Anesthesiologists (ASA) physical status classification of II-III * Planned for elective cesarean delivery under spinal anesthesia
Exclusion criteria
* Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus * Gestational hypertension or chronic hypertension * Body mass index (BMI) ≥ 35 kg/m² * Known allergy to dexamethasone * Current long-term corticosteroid therapy * Diagnosis of postpartum hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-Spinal Hypotension | From the induction of spinal anesthesia until the completion of surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting (PONV) | From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours) | 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. |
| Duration of Postoperative Analgesia | From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours) | 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). |
Countries
Vietnam
Outcome results
None listed