Hypnosis and Closed-Loop Anesthesia System
LoopHypnosis
Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia
2 other identifiers
interventional
97
1 country
1
Brief Summary
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia. A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 31, 2016
October 1, 2016
1.4 years
July 20, 2012
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
one hour
Secondary Outcomes (6)
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
one hour
pain of injection
one hour
Hemodynamic consequences of induction of anesthesia
one hour
characteristics of the hypnotic procedure
one hour
Patient assessment of the induction of anesthesia
one hour
- +1 more secondary outcomes
Study Arms (2)
Hypnosis
EXPERIMENTALstandard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction
Control
ACTIVE COMPARATORstandard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
Interventions
Eligibility Criteria
You may qualify if:
- adult patients scheduled for a surgical procedure under general anesthesia
You may not qualify if:
- pregnancy, breast feeding woman
- allergy to propofol, soy or peanuts
- history of central nervous system disease
- patient receiving a psychotropic treatment
- patient treated by a psychiatrist or a psychologist
- hypovolemia, high cardiovascular risk
- patients with a pace-maker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Foch
Suresnes, 92151, France
Related Publications (1)
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PMID: 16571963BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Szekely, MD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 24, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 31, 2016
Record last verified: 2016-10