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Completed

NCT Number: NCT00327938

Genetic Variation - The Need for Opioids During 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ulleval University Hospital

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measuring of skin conductance

Device

Tetanic stimuli

Procedure

Primary outcomes

  1. skin conductance response

Sponsors and collaborators

Lead sponsor

Rikshospitalet University Hospital

Other

Registry information

Official study 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?

Important dates

Study start
2006
First posted
May 19, 2006
Registry last updated
Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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