Ketamine and Closed-Loop Anesthesia System
LoopKeta
Influence of Ketamine on a Closed-Loop Anesthesia System
2 other identifiers
interventional
67
1 country
2
Brief Summary
The objective is to evaluate the sparing effect of ketamine on the dose of propofol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2015
CompletedApril 6, 2017
April 1, 2017
2.3 years
December 3, 2013
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
administered dose of propofol during maintenance of anesthesia
day 1
Secondary Outcomes (10)
bispectral index measurement
1 day
administered dose of propofol during induction of anesthesia
day 1
administered doses of remifentanil during induction and maintenance of anesthesia
day 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
day 1
hemodynamic abnormalities requiring treatment
day 1
- +5 more secondary outcomes
Study Arms (2)
Ketamine
EXPERIMENTALPatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia)
Placebo
EXPERIMENTALpatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
Hopital Foch
Suresnes, Hauts de Seine, 92151, France
Clinique Fontaine les Dijons
Fontaine-lès-Dijon, 21121, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 13, 2013
Study Start
July 1, 2013
Primary Completion
October 7, 2015
Study Completion
October 7, 2015
Last Updated
April 6, 2017
Record last verified: 2017-04