Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273130
Status:
TERMINATED
Last Update Posted:
2006-09-13
First Post:
2006-01-05
Brief Title:
Stress Response Using Thin and Standard Size Endoscopy
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope
Status:
TERMINATED
Status Verified Date:
2003-12
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:
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
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
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 45 mm Olympus prototype fiberendoscope introduced transnasally T group B Endoscopy with a thin endoscope 45 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 mgdose 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
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 45 mm Olympus prototype fiberendoscope introduced transnasally T group B Endoscopy with a thin endoscope 45 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 mgdose 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KF01-24597 | None | None | None |