NCT01015651

Assessment of the Nociception During Lumbar Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the accuracy of a new paradigm in measuring the level of nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in response to noxious stimuli in anesthetized patients.

Detailed description

The study aims at exploring the changes in the baroreflex induced by 3 noxious stimulation in anesthetized patients: tracheal intubation, tetanic stimulus, and surgical incision. Patients are randomly assigned to one of 2 groups: remifentanil-2 or remifentanil-4, corresponding to the target effect site concentration of this drug delivered through a TCI system. Other drugs included propofol and cisatracurium. The paradigm exploring the baroreflex collects information continuously recorded of the RR intervals and the changes in systolic arterial pressure, before and during noxious stimuli. The hypothesis is that this paradigm explores nociception as the group with smaller doses in remifentanil will have more cardiovascular reactions in response to noxious stimuli.

Conditions

• Lumbar Surgery

Interventions

Type	Name	Description
DRUG	remifentanil	anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 2 ng/ml.
DRUG	remifentanil	anesthesia is induced and maintained with a target-controlled infusion of remifentanil at 4 ng/ml.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-11-18
• Last updated: 2010-04-07

Locations

1 site across 1 country: France