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The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial

NCT04202887 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-10-20

No results posted yet for this study

Summary

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.

Conditions

  • Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
  • Aspiration

Interventions

DRUG

Low Dose Fentanyl

10ml bolus: bupivacaine 0.1% + 25mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 1mcg/ml

DRUG

High Dose Fentanyl

10ml bolus: bupivacaine 0.1% + 100mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 2mcg/ml

DEVICE

Gastric Ultrasonography

The Gastric US will be performed using a portable device with an abdominal probe by the same operator (EF) for all women. The Cross Sectional Area (CSA) of the antrum will be measured in the supine position with the head elevated 45 degrees. CSA will be calculated using the formula (AP x CC x pi)/4, where AC is the anterio-posterior diameter and CC the cranio-caudal diameter. Three consecutive measurements will be performed and the average of the three will be used as the final data. The cutoff used to define a "full stomach" will be a CSA above 381 mm2, which has been validated in previous studies on laboring woman. Gastric US will be performed immediately after verification of effective epidural analgesia (T0) and intrapartum, two hours after the first measurement (T2h), corresponding to a cumulative dose of 37-97mcg fentanyl in Group LF and 124-240mcg fentanyl in Group HF.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Idit Matot, M.D. · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-10-30
Completion
2020-10-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202887 on ClinicalTrials.gov