Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335010
Status:
COMPLETED
Last Update Posted:
2006-06-08
First Post:
2006-06-07
Brief Title:
Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present study was to investigate if NTG administered intravenously during gastric tube reconstruction could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage
Detailed Description:
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 μHbSO2 and microvascular haemoglobin concentration μHbcon were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck
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 μHbSO2 and microvascular haemoglobin concentration μHbcon were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None