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
About this trial
This is an interventional prevention trial for Upper Gastrointestinal Disease,Ulcers focused on measuring transnasal gastroscopy, stress response, ischaemia
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
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
NCT ID
NCT00273130
First Posted
January 5, 2006
Last Updated
September 11, 2006
Sponsor
Hvidovre University Hospital
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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