Hemodynamic stability and tissue oxygenation during balanced propofol remifentanil-based anaesthesia with high level of analgesia
| ISRCTN | ISRCTN20153044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20153044 |
| Secondary identifying numbers | CM-01 |
- Submission date
- 19/06/2012
- Registration date
- 13/07/2012
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
University Medical Center Groningen
Hanzeplein 1
PO Box 30 001
Groningen
9700RB
Netherlands
Study information
| Study design | Single-center observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Hemodynamic stability and tissue oxygenation during balanced propofol remifentanil-based anaesthesia with high level of analgesia: an observational study |
| Study objectives | 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(s) | Medical Ethical Committee (METC), University Medical Center Groningen [Medisch Ethische Toetsingscommissie, Universitair Medisch Centrum Groningen], 15/04/2011, ref 2011.052 |
| Health condition(s) or problem(s) studied | Tissue oxygenation and hemodymanics in anesthesia |
| Intervention | Administration of norepinephrine following good clinical practice. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Age >18 years 2. Patients planned for ophtalmic surgery under general anesthesia |
| Key exclusion criteria | 1. Unwilling/unable to written informed consent 2. Neuropsychiatric history |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
9700RB
Netherlands
Sponsor information
Hospital/treatment centre
Hanzeplein 1
PO Box 30 001
Groningen
9700RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- University Medical Center Groningen, UMCG
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/10/2014 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference and total final enrolment added.
30/06/2017: Plain English summary added.
