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Stress Response Using Thin and Standard Size Endoscopy.

Primary Purpose

Upper Gastrointestinal Disease,Ulcers

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
transnasal endoscopy
transoral thin endoscopy
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Gastrointestinal Disease,Ulcers focused on measuring transnasal gastroscopy, stress response, ischaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnostic gastroscopy, age over 18, danish speaking, Exclusion Criteria: use of beta blocking or any other heart rate modulating drug, antithyroid drugs

Sites / Locations

  • Hvidovre University Hospital, Dept of Surgery

Outcomes

Primary Outcome Measures

tachycardia, ischaemia, level of stress response

Secondary Outcome Measures

acceptability of transnasal endoscopy

Full Information

First Posted
January 5, 2006
Last Updated
September 11, 2006
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00273130
Brief Title
Stress Response Using Thin and Standard Size Endoscopy.
Official Title
Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Terminated
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

5. Study Description

Brief Summary
Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups. transnasal gastroscopy with thin endoscope transoral with thin endoscope standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.
Detailed Description
A substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. Recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .Hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. Furthermore the patient tolerance is markedly improved compared to the standard transoral route. The aim of the present randomised study was to evaluate the ECG-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally. Method and material Sixty patients were included consecutively after written and informed consent and were all over 18 years. Patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. Patients with known disease or trauma of the nasal cavity were not included. Only intended diagnostic upper gastrointestinal endoscopies were included. The patients received standard medication during the endoscopy if required. Immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups A) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced transnasally (T group), B) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced orally (O group) or C) Endoscopy with a standard gastroscope (6 mm Olympus GIF XV10) (S group). All patients received the same amount of a local anesthetic spray (Lidocaine 10 mg/dose, ASTRA Zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Disease,Ulcers
Keywords
transnasal gastroscopy, stress response, ischaemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
transnasal endoscopy
Intervention Type
Procedure
Intervention Name(s)
transoral thin endoscopy
Primary Outcome Measure Information:
Title
tachycardia, ischaemia, level of stress response
Secondary Outcome Measure Information:
Title
acceptability of transnasal endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnostic gastroscopy, age over 18, danish speaking, Exclusion Criteria: use of beta blocking or any other heart rate modulating drug, antithyroid drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Christensen, MD
Organizational Affiliation
Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital, Dept of Surgery
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Stress Response Using Thin and Standard Size Endoscopy.

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