Assessment of the Nociception During Lumbar Surgery

Not Applicable

Completed

• Conditions: Lumbar Surgery
• Interventions: Drug: remifentanil

• Registration Number: NCT01015651
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-06
• Last Update Posted: 2010-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• ASA classification I-II
• undergoing lumbar surgery for discal hernia
• body mass index <30 kg/m2

Exclusion Criteria

• ASA classification III-IV
• cardiac history that precludes RR recording : atrial fibrillation, arterial hypertension, active cardiac pacing, chronic treatment with beta-blockers, alpha-blockers, calcium-blockers and angiotensin receptors inhibitors
• diabetes
• regular intake of cocaine, alcohol
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil-2	remifentanil	In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 2 ng/ml.
remifentanil-4	remifentanil	In this group, patients are receiving a continuous i.v. infusion of remifentanil according to a target effect site concentration of 4 ng/ml.

Primary Outcome Measures

Name	Time	Method
changes in the baroreflex in response to noxious stimuli	intraoperative

Secondary Outcome Measures

Name	Time	Method
perioperative requirements in anesthetic agents.	intraoperative

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France