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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 April 2024
Main ID:	NCT01467167
Date of registration:	14/09/2011
Prospective Registration:	Yes
Primary sponsor:	University Medical Center Groningen
Public title:	Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Scientific title:	Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Date of first enrolment:	October 2011
Target sample size:	400
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT01467167
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Netherlands	Switzerland

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Elective surgery

- General anesthesia

- American Society of Anesthesiologists Physical Status: I - III

- Age 18 to 90 years

Exclusion Criteria:

- Combined regional and general anesthesia

- Expected surgery duration < 30 minutes

- Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures,
psychiatric diseases)

- Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics,
anticonvulsants)

- Heart surgery on cardio-pulmonary bypass

- Relevant hepatic disease (Child B or higher)

- BMI >35

- Overt signs of alcohol abuse

- Contraindications or allergies to drugs used in the study

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia,General

Intervention(s)

Primary Outcome(s)

Anesthesia Quality Score [Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)]

Secondary Outcome(s)

Number of doses of vasoactive substances [Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)]

Early postoperative pain control measured by visual analog scale and total morphine dose [Time Frame: up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)]

Mean intra-operative Noxious Stimulation Response Index (NSRI) [Time Frame: 1 day During surgery (until skin closure)]

Workload of anesthesist, measured by the NASA Taskload Index [Time Frame: up to 1 day From start of induction until transportation to PACU]

Number of events with motor and vegetative (tearing, sweating) responses [Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit]

Recovery times (skin closure to extubation; skin closure to orientation) [Time Frame: up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)]

Total anesthetic drug doses [Time Frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)]

Secondary ID(s)

SPV_Utility_V7

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Insel Gruppe AG, University Hospital Bern

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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