Stress Response Using Thin and Standard Size Endoscopy.

September 11, 2006 updated by: Hvidovre University Hospital

Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital, Dept of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnostic gastroscopy, age over 18, danish speaking,

Exclusion Criteria:

  • use of beta blocking or any other heart rate modulating drug, antithyroid drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
tachycardia, ischaemia, level of stress response

Secondary Outcome Measures

Outcome Measure
acceptability of transnasal endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Merete Christensen, MD, Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-01-KAT
  • KF01-245/97

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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