Genetic Variation – The Need for Opioids During Surgery

Pain Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327938
• Other study ID #: 2.2005.2354
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: April 19, 2007
• Start date: May 2006

Study information

• Verified date: April 2007
• Source: Rikshospitalet University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Measuring of skin conductance

Procedure:
• Tetanic stimuli

Locations

Country	Name	City	State
Norway	Ulleval University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin conductance response