Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00273130 |
| Other study ID # |
MC-01-KAT |
| Secondary ID |
KF01-245/97 |
| Status |
Terminated |
| Phase |
Phase 2/Phase 3
|
| First received |
January 5, 2006 |
| Last updated |
September 11, 2006 |
| Start date |
March 1999 |
| Est. completion date |
August 2002 |
Study information
| Verified date |
December 2003 |
| Source |
Hvidovre University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: National Ministry of Health, Copenhagen |
| Study type |
Interventional
|
Clinical Trial Summary
Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written
informed consent into three groups.
1. transnasal gastroscopy with thin endoscope
2. transoral with thin endoscope
3. standard size trans-oral endoscopy Stress response parameters (epinephrine,
nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were
monitored.
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).
