HemorrhoidsNCT00328900
Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine
A study testing Administration of 0,7 mg of atropine and Measurement of skin conductance with Pain detector in people with Hemorrhoids and Fissure in Ano, run by Rikshospitalet University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Fissure in Ano
- What is being tested?
- Administration of 0,7 mg of atropine and Measurement of skin conductance with Pain detector
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in ASA-group 1-2
- Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour
- informed consent
- BMI <30
Who cannot join
- Patients using any medication known to influence the autonomous nervous system
- Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect)
- BMI >30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ulleval University Hospital
Oslo, 0407
Hanne Storm, PhD, +47 23074398, hanne.storm@medisin.uio.no
About this study
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.
Read the 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.
- Conditions
- Hemorrhoids, Fissure in Ano
- Being tested
- Administration of 0,7 mg of atropine, Measurement of skin conductance with Pain detector
- Keywords
- Galvanic skin response, Anesthesia, Atropine
- Medical subject headings
- Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of 0,7 mg of atropineDrug
Measurement of skin conductance with Pain detectorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of skin conductance fluctuations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rikshospitalet University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hanne Storm, PhD, Study director, Rikshospitalet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328900
- Sponsor's protocol ID
- S-03113
- Status last verified
- Apr 2007
- First submitted
- 22 May 2006
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine
- ClinicalTrials.gov ID
- NCT00328900
- Acronym / sponsor ID
- S-03113
- Conditions
- Hemorrhoids, Fissure in Ano
- Keywords
- Galvanic skin response, Anesthesia, Atropine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rikshospitalet University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in ASA-group 1-2
- Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour
- informed consent
- BMI <30
Key exclusion criteria (4 listed)
- Patients using any medication known to influence the autonomous nervous system
- Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect)
- BMI >30
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of 0,7 mg of atropine | Drug | – |
| Measurement of skin conductance with Pain detector | Device | – |
Primary outcome
Number of skin conductance fluctuations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Storm, PhD study director
Rikshospitalet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of 0,7 mg of atropine and Measurement of skin conductance with Pain detector in people with Hemorrhoids and Fissure in Ano, run by Rikshospitalet University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne Storm, PhD (+47 23074398, hanne.storm@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of skin conductance fluctuations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.