Factors Influencing Anesthetic Drug Requirement

Study Overview
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Brief Summary
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The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

Official Title
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Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Closed loop anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study Exclusion Criteria: Age under 18 years Pregnancy, breastfeeding woman Allergy to propofol, soybeans or peanuts Allergy to sufentanil, remifentanil, morphine, Allergy to a muscle relaxant or to any of its excipients Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl History of central neurological disorder or brain injury Patient with dementia Patient with pacemaker Patient receiving psychotropic drugs or morphine agonist-antagonists Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed loop anesthesia<br> | Device: Closed loop anesthesia<br>* Propofol and Remifentanil are administered automatically using a closed-loop system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia |  | during anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol dose required for anesthesia induction |  | intraoperative period | 
| Remifentanil dose required for anesthesia induction |  | intraoperative period | 
| Remifentanil dose requirements for maintenance of anesthesia |  | intraoperative period | 
| Wake up time |  | intraoperative period | 
| Explicit memorisation |  | post-operative period | 
| Propofol and remifentanil requirements according to the surgical technique |  | post-operative period | 
| Analysis of subgroup of patients according to their clinical status | analysis of subgroup of patients according to their clinical status (eg: age) | post-operative period | 
| Analysis of subgroup of patients according to the surgical approach | analysis of subgroup of patients according to the surgical approach (open surgery versus minimal invasive surgery) | post-operative period | 
| Analysis of subgroup of patients according to their pathology | analysis of subgroup of patients according to their pathology (eg: burns) | post-operative period |