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OpenTrials
Completed

NCT Number: NCT00896714

Factors Influencing Anesthetic Drug Requirement

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).

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed loop anesthesia

Device

Propofol and Remifentanil are administered automatically using a closed-loop system

Primary outcomes

  1. The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia

    Time frame: during anesthesia

Secondary outcomes

  1. Propofol dose required for anesthesia induction

    Time frame: intraoperative period

  2. Remifentanil dose required for anesthesia induction

    Time frame: intraoperative period

  3. Remifentanil dose requirements for maintenance of anesthesia

    Time frame: intraoperative period

  4. Wake up time

    Time frame: intraoperative period

  5. Explicit memorisation

    Time frame: post-operative period

  6. Propofol and remifentanil requirements according to the surgical technique

    Time frame: post-operative period

  7. Analysis of subgroup of patients according to their clinical status

    Time frame: post-operative period

    analysis of subgroup of patients according to their clinical status (eg: age)

  8. Analysis of subgroup of patients according to the surgical approach

    Time frame: post-operative period

    analysis of subgroup of patients according to the surgical approach ("open" surgery versus "minimal invasive" surgery)

  9. Analysis of subgroup of patients according to their pathology

    Time frame: post-operative period

    analysis of subgroup of patients according to their pathology (eg: burns)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: PosoAnes

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
May 12, 2009
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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