To guide the analgesic component of anesthesia using the Nociceptive Level (NoL) index in ASA 1-3 patients under general anesthesia for elective abdominal surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anesthesie/chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Opioid and propofol consumption in total dose and dose/min; and
2. Incidence (number of episodes) and total duration of inadequate anesthesia
(as derived from heart rate, blood pressure, BIS values and somatic arousal)
Secondary outcome
1. Differences in Pk (prediction probability) values of NoL, BIS, HR and MAP
for predicting the balance of nociception-anti nociception during the following
states
• Awake vs. loss of consiousness (LOC)
• Anesthesia (after discontinuation of propofol and remifentanil) vs. opening
eyes
• LOC vs intubation
• Normal stimulation vs maximum stimulation (as indicated by the surgeon);
2. Incidence of NoL values < 10 and > 20;
3. Time from reversal of neuromuscular blockade to extubation;
4. Pain and sedation scores, incidence of nausea/vomiting, hemodynamics,
respiration and medication use (e.g. opioids and antiemetics) in the recovery
room obtained at 15-min interval;
5. PACU: time until Aldrete > 9 (readiness for discharge);
6. Incidence of memory/awareness.
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.
Study objective
To guide the analgesic component of anesthesia using the Nociceptive Level
(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.
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: 18-80 years;
2. ASA I-II-III
3. Elective open abdominal surgery or laparoscopic assisted abdominal 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;
5. BMI > 35 kg/m2;
6. Uncontrolled preoperative hypo- or hypertension (Mean arterial pressure < 60 mmHg or > 100 mmHg)
7. Preoperative Heart rate < 45/min or > 90/min;
8. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures);
9. Illicit substance or alcohol abuse within 30 days;
10. Chronic use of pain medication within 30 days;
11. Chronic use of psychoactive drugs within 30 days;
12. Significant medical condition
a. Untreated or persistent peripheral or central cardiovascular disease
b. Severe pulmonary disease e.g. COPD gold 4 , FEV< 1.0 L/s, or (evidence of) elevated paCO2 > 6.0 kPa
c. Significant hepatic disease with increased bilirubin, INR or low albumin
13. Beta blocker use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56370.058.15 |
| OMON | NL-OMON28148 |