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IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube

NCT04878926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-10

No results posted yet for this study

Summary

Objective: To determine the effectiveness and safety of IV sedation combined with ultrasound-guided, left side transversus abdominis plane (TAP) block versus combination with local anesthetic (LA) infiltration for Percutaneous Endoscopic Gastrostomy (PEG) tube placement.

Background: The procedure used to be done with general anesthesia or IV sedation with LA infiltration, but the use of IV sedation with TAP block may be another option.

Patients and Methods: This was a prospective randomized study including 60 patients, requiring long-term nutritional support, underwent the PEG procedure at the GIT endoscopy unit at our Hospital. Patients were randomly allocated into two equal groups, in group A; procedures were performed with IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block, while in group B; procedures were performed with IV midazolam and propofol-based sedation with LA infiltration.

Conditions

  • Transversus Abdominis Plane (TAP) Block

Interventions

PROCEDURE

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

PROCEDURE

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Sponsors & Collaborators

  • Damanhour Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Ahmed M Shaat · Damanhour Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-03-01
Completion
2018-03-01

Countries

  • Egypt

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 NCT04878926 on ClinicalTrials.gov