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A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction


N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Neoplasms, Microcirculation

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Trial Information

A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction


Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis,
which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We
recently demonstrated that peri-operatively decreased MBF could be improved by topical
administration of nitro-glycerine NTG). In this present study we investigate the effect of
intravenous NTG on gastric microcirculation.

This single centre, prospective, double blinded study randomized thirty-two patients
scheduled for esophagectomy into two groups. The intervention group received intravenous NTG
during gastric tube reconstruction, as the control group received normal saline.

Baseline values of MBF, microvascular haemoglobin O2 saturation (╬╝HbSO2), and microvascular
haemoglobin concentration (╬╝Hbcon) were determined at the gastric fundus before and after
gastric tube construction and after pulling up the gastric tube to the neck.


Inclusion Criteria:



- Planned esophagectomy with gastric tube reconstruction

- written informed consent

- ASA I and II

Exclusion Criteria:

- younger than 18

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

differences in Microvascular bloodflow

Principal Investigator

Diederik Gommers, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Erasmus MC

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC-2004-160

NCT ID:

NCT00335010

Start Date:

May 2005

Completion Date:

December 2005

Related Keywords:

  • Esophageal Neoplasms
  • Microcirculation
  • Nitroglycerine
  • gastroesophageal anastomosis
  • microvascular bloodflow
  • microvascular hemoglobinsaturation
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

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