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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

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

NCT ID

NCT00328900

First Posted

May 22, 2006

Last Updated

May 31, 2012

Sponsor

Rikshospitalet University Hospital

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

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanne Storm, PhD

Phone

+47 23074398

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

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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