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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by Rikshospitalet University Hospital. Recruitment status was Recruiting

First Received on May 22, 2006. Last Updated on April 19, 2007 History of Changes

Sponsor:	Rikshospitalet University Hospital
Information provided by:	Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:	NCT00328900

Purpose

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.

Condition	Intervention
Hemorrhoids Fissure in Ano	Drug: Administration of 0,7 mg of atropine Device: Measurement of skin conductance with Pain detector

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:

Number of skin conductance fluctuations

Estimated Enrollment:	24
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328900

Contacts

Contact: Hanne Storm, PhD

+47 23074398

hanne.storm@medisin.uio.no

Locations

Norway
Ulleval University Hospital	Recruiting
Oslo, Norway, 0407
Contact: Hanne Storm, PhD +47 23074398 hanne.storm@medisin.uio.no

Sponsors and Collaborators

Rikshospitalet University Hospital

Investigators

Study Director:

Hanne Storm, PhD

Rikshospitalet University Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00328900 History of Changes
Other Study ID Numbers:	S-03113
Study First Received:	May 22, 2006
Last Updated:	April 19, 2007
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet University Hospital:

Galvanic skin response
Anesthesia
Atropine

Additional relevant MeSH terms:

Fissure in Ano
Hemorrhoids
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Atropine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 12, 2012