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

Not Applicable

Terminated

• Conditions: General Anesthesia
• Interventions: Procedure: ANI guided remifentanil; Procedure: ANI blind arm

• Registration Number: NCT01893723
• Lead Sponsor: University Hospital, Lille

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 ?

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia	end of surgery (around 60 to 90 min after start)

Secondary Outcome Measures

Name	Time	Method
total administered remifentanil	end of surgery
number of target changes	end of surgery (around 60 to 90 min after start)
morphine sulfate total administration after end of surgery	during two hours after end of surgery
Visual Analog Scale evaluation of pain after surgery	during two hours after end of surgery
number of bradycardia and hypotension	from start to end of surgery (around 60 to 90 min )
ANI measure during surgery	from start to end of surgery (around 60 to 90 min)
total administered dose of ephedrine	between start and end of anesthesia

Trial Locations

Locations (5)

University Hospital Erasme (ULB); 🇧🇪 Brussel, Belgium

Clinique privée d'ANTONY; 🇫🇷 Antony, France

University Hospital; 🇫🇷 Saint Etienne, France

University Hospital Roger Salengro; 🇫🇷 Lille, France

University Hospital Claude Huriez; 🇫🇷 Lille, France