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

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.
 
ClinicalTrials.gov Identifier: NCT00328900
Recruitment Status : Unknown
Verified April 2007 by Rikshospitalet University Hospital.
Recruitment status was:  Recruiting
First Posted : May 24, 2006
Last Update Posted : June 1, 2012
Sponsor:
Information provided by:
Rikshospitalet University Hospital

Tracking Information
First Submitted Date  ICMJE May 22, 2006
First Posted Date  ICMJE May 24, 2006
Last Update Posted Date June 1, 2012
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2007)
Number of skin conductance fluctuations
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2007)
24
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00328900
Other Study ID Numbers  ICMJE S-03113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanne Storm MD.PhD, Rikshospitalet, UIO
Study Sponsor  ICMJE Rikshospitalet University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hanne Storm, PhD Rikshospitalet University Hospital
PRS Account 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