Clinical trial NCT00273130: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Upper Gastrointestinal Disease,Ulcers
Keywords: transnasal gastroscopy, stress response, ischaemia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

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

Primary outcomes:
measure: tachycardia, ischaemia, level of stress response
Secondary outcomes:
measure: acceptability of transnasal endoscopy
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital, Dept of Surgery
Study officials:
affiliation: Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen
name: Merete Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References: