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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Rikshospitalet University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328900
First Posted: May 24, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rikshospitalet University Hospital
  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: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hanne Storm MD.PhD, Rikshospitalet, UIO
ClinicalTrials.gov Identifier: NCT00328900     History of Changes
Other Study ID Numbers: S-03113
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: October 12, 2017
Last Verified: April 2007

Keywords provided by Rikshospitalet University Hospital:
Galvanic skin response
Anesthesia
Atropine

Additional relevant MeSH terms:
Hemorrhoids
Fissure in Ano
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action