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

U

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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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