Aspiration Clinical Trial
Official title:
The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial
Verified date | October 2020 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates the effect of epidural fentanyl on gastric emptying in non-fasted laboring women. Half the women will be randomized to receive low-dose epidural fentanyl (<100 mcg), and half will be randomized to receive high-dose epidural fentanyl (≥100 mcg). Gastric content will be measured by ultrasonography two hours after epidural placement and compared between the groups.
Status | Active, not recruiting |
Enrollment | 81 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Laboring women =18 years of age - =37 weeks gestation - Singleton pregnancy with cephalad fetus - Cervical dilatation less than 5cm - Request for epidural analgesia Exclusion Criteria: - Contraindications to neuraxial analgesia - Chronic opioid consumption - Increased risk of emergency cesarean delivery - Trial of labor after cesarean delivery (TOLAC), twin pregnancy, non-reassuring fetal heart rate (NRFHR), dysfunctional labor, estimated fetal weight>4000g, body mass index (BMI) = 40kg/m2. - Increased risk of aspiration - Disorders of the upper gastrointestinal tract (severe gastro-esophageal reflux, history of bariatric surgery), neurological and endocrine disorders associated with gastroparesis (such as multiple sclerosis, diabetes with autonomic neuropathy) - BMI > 40kg/m2 |
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CSA two hours after epidural placement | CSA measured by ultrasonography two hours after first measurement (at T2h) in "High dose Fentanyl" (HF) versus "Low dose Fentanyl" (LF) | 2 hours after epidural placement | |
Secondary | Change in CSA from baseline in HF versus LF | Comparison of CSA at 2h for subgroups - LF/Empty vs. HF/Empty and of LF/Full vs. HF/Full , and comparison of CSA-baseline vs. CSA-2h for each subgroup. | Baseline and at 2 hours |
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