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Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine

Primary Purpose

Hemorrhoids, Fissure in Ano

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Administration of 0,7 mg of atropine
Measurement of skin conductance with Pain detector
Sponsored by
Rikshospitalet University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhoids focused on measuring Galvanic skin response, Anesthesia, Atropine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients in ASA-group 1-2 Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour informed consent BMI <30 Exclusion Criteria: Patients using any medication known to influence the autonomous nervous system Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect) BMI >30 Pregnancy

Sites / Locations

  • Ulleval University HospitalRecruiting

Outcomes

Primary Outcome Measures

Number of skin conductance fluctuations

Secondary Outcome Measures

Full Information

First Posted
May 22, 2006
Last Updated
May 31, 2012
Sponsor
Rikshospitalet University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00328900
Brief Title
Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rikshospitalet University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
24 patients randomly divided into two groups, one of the groups receiving atropine in addition to the planned anaesthesia. Skin conductance parameters to be compared between the two groups.
Detailed Description
Skin conductance (SC), in terms of numbers of skin conduction fluctuations (NSCF), amplitude and mean skin conductance level, reflect the activity in the sympathetic postganglionic cholinergic fibers which innervate the palmar and plantar sweat glands. Skin conductance, especially numbers of skin conductance fluctuations, may be a promising tool to monitor anesthesia. Atropine, an anticholinergic agent, acts as an antagonist on the muscarinic receptors of the sweat glands and inhibits their secretion in a dose-dependent way. The aim of this study was to find out to what degree SC is influenced by i.v. administration of atropine. Study hypothesis: SC is not influenced by i.v. administration of atropine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Fissure in Ano
Keywords
Galvanic skin response, Anesthesia, Atropine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Administration of 0,7 mg of atropine
Intervention Type
Device
Intervention Name(s)
Measurement of skin conductance with Pain detector
Primary Outcome Measure Information:
Title
Number of skin conductance fluctuations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in ASA-group 1-2 Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour informed consent BMI <30 Exclusion Criteria: Patients using any medication known to influence the autonomous nervous system Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect) BMI >30 Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Storm, PhD
Phone
+47 23074398
Email
hanne.storm@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Storm, PhD
Organizational Affiliation
Rikshospitalet University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Storm, PhD
Phone
+47 23074398
Email
hanne.storm@medisin.uio.no

12. IPD Sharing Statement

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Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine

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