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Genetic Variation – The Need for Opioids During Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327938
First Posted: May 19, 2006
Last Update Posted: April 20, 2007
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
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.

Condition Intervention
Pain Device: Measuring of skin conductance Procedure: Tetanic stimuli

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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?

Further study details as provided by Rikshospitalet University Hospital:

Primary Outcome Measures:
  • skin conductance response

Estimated Enrollment: 50
Study Start Date: May 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Chronic pain in the last 6 months or recent use and abuse of analgesics.
  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): NCT00327938


Locations
Norway
Ulleval University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Rikshospitalet University Hospital
Investigators
Study Director: Hanne Storm, PhD Rikshospitalet University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00327938     History of Changes
Other Study ID Numbers: 2.2005.2354
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by Rikshospitalet University Hospital:
Remifentanil
Skin Conductance
Anesthesia
Analgesics, Opioid

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents