Genetic Variation - The Need for Opioids During Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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

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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

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Measuring of skin conductance

Intervention Type DEVICE

Tetanic stimuli

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Hanne Storm, PhD

Role: STUDY_DIRECTOR

Rikshospitalet University Hospital

Locations

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Ulleval University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2.2005.2354

Identifier Type: -

Identifier Source: org_study_id