Measurement of Stress During Anesthesia With ”Pain Detector” on Patients Receiving Atropine - Tabular View

Tracking Information

First Received Date ^ICMJE

May 22, 2006

Last Updated Date

April 19, 2007

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Number of skin conductance fluctuations

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00328900 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Uncontrolled, Factorial Assignment

Condition ^ICMJE

Hemorrhoids
Fissure in Ano

Intervention ^ICMJE

Drug: Administration of 0,7 mg of atropine
Device: Measurement of skin conductance with Pain detector

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hanne Storm, PhD

+47 23074398

hanne.storm@medisin.uio.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00328900

Responsible Party

Study ID Numbers ^ICMJE

S-03113

Study Sponsor ^ICMJE

Rikshospitalet University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Hanne Storm, PhD

Rikshospitalet University Hospital

Information Provided By

Rikshospitalet University Hospital

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP