PainNCT00327938
Genetic Variation - The Need for Opioids During Surgery
A study testing Measuring of skin conductance and Tetanic stimuli in people with Pain, run by Rikshospitalet University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin conductance response can be used as a test in patients before surgery to have an indication about what amount of analgesics the patient will need during surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Measuring of skin conductance and Tetanic stimuli
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- May 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women in American Society of Anesthesiologists (ASA) group 1-2 and with body mass index between 20 and 30 and going through laparoscopic surgery at the Gynecological Department, Ullevål University Hospital.
- Normal renal and hepar function (serum albumin and serum creatinine should be within the normal limit).
Who cannot join
- Chronic pain in the last 6 months or recent use and abuse of analgesics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetically Variation - May the Need of Opioids During Surgery be Known Beforehand by Giving Noxious Stimulation and Measure the Skin Conductance Response Before Surgery?
The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin conductance response can be used as a test in patients before surgery to have an indication about what amount of analgesics the patient will need during surgery.
Read the detailed description
Skin Conductance (SC) shows the emotional state as reflected in changes in the sympathetic nervous system. During sleep or other states of low basic sympathetic activity, activation of the sympathetic nervous system results in filling of the palmar and plantar sweat glands, and the SC increases transiently before the sweat is removed and the SC decreases again. When a short lasting outgoing sympathetic nervous burst occurs, fluctuations of SC will follow. An increase in the number of SC fluctuations (NSCF) can therefore be interpreted as increased activity in this part of the sympathetic nervous system. When remifentanil, an opioid analgetic is given, NSCF is reduced.
Genetic variation influences the pharmacokinetics and the pharmacodynamics of analgesics like morphine derivates and remifentanil. 50 female patients will therefore be blood tested to study if they are Val/Val or Met/Met for the COMT gene, or if they are homozygous or heterozygous for the 118G allele and the 118A allele.
This study will show if skin conductance can be used to measure noxious stimulation response before surgery (by giving a tetanic stimuli), and then predict what level of analgesic a patient will need during surgery.
- Conditions
- Pain
- Being tested
- Measuring of skin conductance, Tetanic stimuli
- Keywords
- Remifentanil, Skin Conductance, Anesthesia, Analgesics, Opioid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring of skin conductanceDevice
Tetanic stimuliProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
skin conductance response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants
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
- NCT00327938
- Sponsor's protocol ID
- 2.2005.2354
- Status last verified
- Apr 2007
- First submitted
- 18 May 2006
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetically Variation - May the Need of Opioids During Surgery be Known Beforehand by Giving Noxious Stimulation and Measure the Skin Conductance Response Before Surgery?
- ClinicalTrials.gov ID
- NCT00327938
- Acronym / sponsor ID
- 2.2005.2354
- Conditions
- Pain
- Keywords
- Remifentanil, Skin Conductance, Anesthesia, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Rikshospitalet University HospitalUniversity, hospital or other
- Study start
- May 2006
- First posted
- 19 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.
The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin conductance response can be used as a test in patients before surgery to have an indication about what amount of analgesics the patient will need during surgery.
Detailed description
Skin Conductance (SC) shows the emotional state as reflected in changes in the sympathetic nervous system. During sleep or other states of low basic sympathetic activity, activation of the sympathetic nervous system results in filling of the palmar and plantar sweat glands, and the SC increases transiently before the sweat is removed and the SC decreases again. When a short lasting outgoing sympathetic nervous burst occurs, fluctuations of SC will follow. An increase in the number of SC fluctuations (NSCF) can therefore be interpreted as increased activity in this part of the sympathetic nervous system. When remifentanil, an opioid analgetic is given, NSCF is reduced.
Genetic variation influences the pharmacokinetics and the pharmacodynamics of analgesics like morphine derivates and remifentanil. 50 female patients will therefore be blood tested to study if they are Val/Val or Met/Met for the COMT gene, or if they are homozygous or heterozygous for the 118G allele and the 118A allele.
This study will show if skin conductance can be used to measure noxious stimulation response before surgery (by giving a tetanic stimuli), and then predict what level of analgesic a patient will need during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women in American Society of Anesthesiologists (ASA) group 1-2 and with body mass index between 20 and 30 and going through laparoscopic surgery at the Gynecological Department, Ullevål University Hospital.
- Normal renal and hepar function (serum albumin and serum creatinine should be within the normal limit).
Key exclusion criteria (1 listed)
- Chronic pain in the last 6 months or recent use and abuse of analgesics.
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 |
|---|---|---|
| Measuring of skin conductance | Device | – |
| Tetanic stimuli | Procedure or surgery | – |
Primary outcome
skin conductance response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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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 Measuring of skin conductance and Tetanic stimuli in people with Pain, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin conductance response. 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 20 Apr 2007.