Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- ANI guided remifentanil
- Conditions
- General Anesthesia
- Sponsor
- University Hospital, Lille
- Enrollment
- 37
- Locations
- 10
- Primary Endpoint
- Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
- Status
- Completed
- Last Updated
- 11 days ago
Overview
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 ?
Investigators
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
Arms & Interventions
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.
Intervention: ANI guided remifentanil
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.
Intervention: ANI blind arm
Outcomes
Primary Outcomes
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
Time Frame: end of surgery (around 60 to 90 min after start)
Secondary Outcomes
- 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)