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

General Anesthesia Clinical Trial

— AIVOC-ANI  

Official title:

Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01893723
• Other study ID #: 2010_51
• Secondary ID: 2011-A00947-34
• Status: Terminated
• Phase: N/A
• First received: June 18, 2013
• Last updated: November 3, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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 ?

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 ?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• ANI guided remifentanil
remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
• ANI blind arm
remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided

Locations

Country	Name	City	State
Belgium	University Hospital Erasme (ULB)	Brussel
France	Clinique privée d'ANTONY	Antony
France	University Hospital Claude Huriez	Lille
France	University Hospital Roger Salengro	Lille
France	University Hospital	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia		end of surgery (around 60 to 90 min after start)	No
Secondary	total administered remifentanil		end of surgery	No
Secondary	number of target changes		end of surgery (around 60 to 90 min after start)	No
Secondary	morphine sulfate total administration after end of surgery		during two hours after end of surgery	No
Secondary	Visual Analog Scale evaluation of pain after surgery		during two hours after end of surgery	No
Secondary	ANI measure during surgery		from start to end of surgery (around 60 to 90 min)	No
Secondary	number of bradycardia and hypotension		from start to end of surgery (around 60 to 90 min )	No
Secondary	total administered dose of ephedrine		between start and end of anesthesia	No