Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery (AIVOC-ANI)

University Hospital, Lille

Status: Terminated

Conditions: General Anesthesia

Treatments: Procedure: ANI blind arm; Procedure: ANI guided remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01893723

2010_51

2011-A00947-34 (Other Identifier)

Details and patient eligibility

About

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 ?

Full 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 ?

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

ANI guided remifentanil arm

Experimental group

Description:

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

Treatment:

Procedure: ANI guided remifentanil

ANI blind arm

Other group

Description:

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.

Treatment:

Procedure: ANI blind arm