Factors Influencing Anesthetic Drug Requirement

Anesthesia, General Clinical Trial

— PosoAnes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896714
• Other study ID #: 2008/44
• Status: Completed
• Phase: N/A
• Start date: May 4, 2009
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3278
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• Closed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	Centre Hospitalier de Dreux	Dreux
France	Hôpital Tenon	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia		during anesthesia
Secondary	Propofol dose required for anesthesia induction		intraoperative period
Secondary	Remifentanil dose required for anesthesia induction		intraoperative period
Secondary	Remifentanil dose requirements for maintenance of anesthesia		intraoperative period
Secondary	Wake up time		intraoperative period
Secondary	Explicit memorisation		post-operative period
Secondary	Propofol and remifentanil requirements according to the surgical technique		post-operative period
Secondary	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
Secondary	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
Secondary	Analysis of subgroup of patients according to their pathology	analysis of subgroup of patients according to their pathology (eg: burns)	post-operative period