NCT00328900

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
Last Updated

June 1, 2012

Status Verified

April 1, 2007

First QC Date

May 22, 2006

Last Update Submit

May 31, 2012

Conditions

HemorrhoidsFissure in Ano

Keywords

Galvanic skin responseAnesthesiaAtropine

Outcome Measures

Primary Outcomes (1)

  • Number of skin conductance fluctuations

Interventions

Administration of 0,7 mg of atropineDRUG
Measurement of skin conductance with Pain detectorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in ASA-group 1-2
  • Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour
  • informed consent
  • BMI \<30

You may not qualify if:

  • Patients using any medication known to influence the autonomous nervous system
  • Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect)
  • BMI \>30
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, 0407, Norway

RECRUITING

MeSH Terms

Conditions

HemorrhoidsFissure in Ano

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesAnus Diseases

Study Officials

  • Hanne Storm, PhD

    Rikshospitalet University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hanne Storm, PhD

CONTACT

+47 23074398hanne.storm@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

January 1, 2006

Last Updated

June 1, 2012

Record last verified: 2007-04

Locations

NO(1)