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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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