To guide the analgesic component of anesthesia using the NOL index in ASA 1-3 patients under general anesthesia for elective abdominal surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
perioperatieve patienten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperartive pain
Secondary outcome
Opioid and propofol consumption in total dose and dose/min; and
Incidence (number of episodes) of inadequate anesthesia (as derived from heart
rate, blood pressure, BIS values)
Background summary
Inadequate (under-dosing) as well as excessive (overdosing) levels of analgesia
and anesthesia are associated with poor patient outcome. Currently, the
analgesic component of anesthesia is steered using traditional indices, such as
heart rate and blood pressure. However, the use of these indirect parameters
for nociception is inaccurate and often results in under- or overdosing of
anesthetics. Recently a newly developed index, the Nociceptive Level (NOL)
index was validated and showed superiority over heart rate and blood pressure
in relation to intense and mild nociceptive stimuli. In this study we will
assess the effect of NOL guided anesthesisa (fentanyl/sevoflurane/rocuronium)
on postoperative pain and opioid consumption
Study objective
To guide the analgesic component of anesthesia using the NOL index in ASA 1-3
patients under general anesthesia for elective abdominal surgery.
Study design
A randomized, double blinded, controlled trial in which standard care
anesthesia and NoL-guided anesthesia will be compared in ASA I-III patients
requiring elective abdominal surgery under general anesthesia.
Intervention
NOL-guided versus standard of care anesthesia
Study burden and risks
None
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age: 18 years and older;
2. ASA I-II-III
3. Elective surgery
Exclusion criteria
1. Unable to give written informed consent;
2. Use of epidural analgesia or local anesthesia (eg. transversus abdominal plain block, TAP block)
3. Non-elective surgery
4. Pregnancy/lactation.
6. Uncontrolled preoperative hypo- or hypertension (Mean arterial pressure < 60 mmHg or systolic blood pressure > 160 mmHg)
7.Preoperative Heart rate < 45/min or > 90/min;
8. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptische aanvallen);
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL68563.058.18 |