Condition category
Surgery
Date applied
19/06/2012
Date assigned
13/07/2012
Last edited
30/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
On some occasions, general anesthetic with a high antinociceptive (pain-blocking) effect is required although it might cause hypotension (low blood pressure). The aim of this study is to investigate whether a high-antinociceptive general anesthetic, together with fluids and norepinephrine, results in preservation of tissue oxygen levels and cardiac (heart) output.

Who can participate?
Patients aged over 18 scheduled to receive general anesthetic for surgery that requires a high level of antinociception

What does the study involve?
General anesthetic is administered following normal clinical practice guidelines, during which tissue oxygen levels and cardiac output are measured non-invasively.

What are the possible benefits and risks of participating?
There are no benefits or risks for participants because it is an observational study and normal clinical practice guidelines are followed.

Where is the study run from?
University Medical Center Groningen (Netherlands)

When is the study starting and how long is it expected to run for?
May 2011 to July 2011

Who is funding the study?
University Medical Center Groningen (Netherlands)

Who is the main contact?
Dr Alain Kalmar

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alain Kalmar

ORCID ID

Contact details

University Medical Center Groningen
Hanzeplein 1
PO Box 30 001
Groningen
9700RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CM-01

Study information

Scientific title

Hemodynamic stability and tissue oxygenation during balanced propofol remifentanil-based anaesthesia with high level of analgesia: an observational study

Acronym

Study hypothesis

A propofol/remifentanil based anesthesia with high stability against intermittent noxious stimuli requires a relatively low level of propofol and a relatively high level of remifentanil to preserve an adequate aneaesthesia, as described by Bouillon. This combination may induce hypotension which can be treated by fluid administration and norepinephrine. Specifically administration of norepinephrine may be controversial in the light of tissue oxygenation and stroke volume. This study investigates whether a moderate administration of norepinephrine, combined with adequate fluid therapy results in preserved cardiac output and tissue oxygenation.

Ethics approval

Medical Ethical Committee (METC), University Medical Center Groningen [Medisch Ethische Toetsingscommissie, Universitair Medisch Centrum Groningen], 15/04/2011, ref 2011.052

Study design

Single-center observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Tissue oxygenation and hemodymanics in anesthesia

Intervention

Administration of norepinephrine following good clinical practice.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Tissue oxygenation, measured continuously and non-invasively using the InSpectra StO2 monitor (Hutchinson Technology, Hutchinson, USA)
2. Cardiac output, measured using Nexfin (BMEye, Amsterdam, Netherlands)

Secondary outcome measures

Time to extubation calculated by measuring the time interval between stopping of the syringes and the moment at which the patient is extubated

Overall trial start date

01/05/2011

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Patients planned for ophtalmic surgery under general anesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Unwilling/unable to written informed consent
2. Neuropsychiatric history

Recruitment start date

01/05/2011

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (Netherlands)

Sponsor details

Hanzeplein 1
PO Box 30 001
Groningen
9700RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Universitair Medisch Centrum Groningen

Alternative name(s)

University Medical Center Groningen, UMCG

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/06/2017: Plain English summary added.