Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery

NCT ID: NCT01893723

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-05-31

Brief Summary

The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?

Detailed Description

The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

ANI guided remifentanil arm

remifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered.

Group Type: EXPERIMENTAL

ANI guided remifentanil

Intervention Type: PROCEDURE

remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided

ANI blind arm

remifentanil target is adapted as is usual during general anesthesia, depending on hemodynamic reactions to nociceptive surgical stimulations. In case of elevated blood pressure despite a maximum target of 10 ng/ml (Minto Pk/pD model), then nicardipine is administered.

Group Type: OTHER

ANI blind arm

Intervention Type: PROCEDURE

remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

Interventions

ANI guided remifentanil

remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided

Intervention Type: PROCEDURE

ANI blind arm

remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• laparoscopic cholecystectomy or gynecological laparoscopic surgery
• ASA I or II
• adult patient
• body mass index between 17 and 33 kg/m2

Exclusion Criteria

• pregnancy
• arrhythmia
• pace maker
• diabetes mellitus
• dysautonomia
• treatment with beta blocking agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu JEANNE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

University Hospital Erasme (ULB)

Brussels, , Belgium

Clinique privée d'ANTONY

Antony, , France

University Hospital Claude Huriez

Lille, , France

University Hospital Roger Salengro

Lille, , France

University Hospital

Saint-Etienne, , France

Countries

Belgium; France

Other Identifiers

2011-A00947-34

Identifier Type: OTHER

Identifier Source: secondary_id

2010_51

Identifier Type: -

Identifier Source: org_study_id