Ketamine and Closed-Loop Anesthesia System

Anesthesia Clinical Trial

— LoopKeta  

Official title:

Influence of Ketamine on a Closed-Loop Anesthesia System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02011347
• Other study ID #: 2012/26
• Secondary ID: 2012-003001-97
• Status: Terminated
• Phase: Phase 3
• First received: December 3, 2013
• Last updated: April 5, 2017
• Start date: July 2013
• Est. completion date: October 7, 2015

Study information

• Verified date: April 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to evaluate the sparing effect of ketamine on the dose of propofol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: October 7, 2015
• Est. primary completion date: October 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with an American Society of Anesthesiology score 1, 2 or 3

• scheduled for a surgical procedure lasting more than 2 hours under general anesthesia

Exclusion Criteria:

• pregnancy

• chronic pain

• simultaneous general and loco-regional anesthesia

• contra-indication to to nonsteroidal anti-inflammatory drug

• contra-indication to Ketamine

• contra-indication to propofol, to remifentanil, to morphine

• history of central nervous system disease

• patients receiving a psychotropic treatment

• patients with a pace-maker

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Ketamine

• Placebo

Locations

Country	Name	City	State
France	Clinique Fontaine les Dijons	Fontaine les Dijon
France	Hopital Foch	Suresnes	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	administered dose of propofol during maintenance of anesthesia		day 1
Secondary	bispectral index measurement	bispectral index modification due to ketamine infusion before induction of anesthesia	1 day
Secondary	administered dose of propofol during induction of anesthesia		day 1
Secondary	administered doses of remifentanil during induction and maintenance of anesthesia		day 1
Secondary	delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia		day 1
Secondary	hemodynamic abnormalities requiring treatment		day 1
Secondary	% of time with a bispectral index between 40 and 60		day 1
Secondary	postoperative morphine requirement		day 1
Secondary	incidence of postoperative nausea and vomiting		day 1
Secondary	White and Song score		day 1
Secondary	% of patients with an explicit memorisation of the intraoperative period		second postoperative day