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Ketamine and Closed-Loop Anesthesia System

Influence of Ketamine on a Closed-Loop Anesthesia System

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02011347
Acronym
LoopKeta
Enrollment
67
Registered
2013-12-13
Start date
2013-07-31
Completion date
2015-10-07
Last updated
2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

Interventions

DRUGKetamine
DRUGPlacebo

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
administered dose of propofol during maintenance of anesthesiaday 1

Secondary

MeasureTime frameDescription
administered dose of propofol during induction of anesthesiaday 1
administered doses of remifentanil during induction and maintenance of anesthesiaday 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesiaday 1
hemodynamic abnormalities requiring treatmentday 1
bispectral index measurement1 daybispectral index modification due to ketamine infusion before induction of anesthesia
postoperative morphine requirementday 1
incidence of postoperative nausea and vomitingday 1
White and Song scoreday 1
% of patients with an explicit memorisation of the intraoperative periodsecond postoperative day
% of time with a bispectral index between 40 and 60day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026