No registrations found.
ID
Source
Brief title
Health condition
- Analgesia
- Anesthesia
- Nociceptive level index
- Intraoperative monitoring
- Haemodynamics
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
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.
Study objective
We hypothesize that, compared with standard management, NoL-guided anesthesia will lead to reduced incidence of inadequate anesthesia and increased hemodynamic stability. Furthermore, we hypothesize that NoL-guided anesthesia leads to reduced recovery times, reduced postoperative pain scores and PONV and faster PACU discharge (readiness) times.
Study design
Perioperative period: intraoperative analgesia consumption and haemodynamics; postoperative pain, medication use, nausea/vomiting
Intervention
Nociceptive level guided analgesia
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6002 |
| NTR-old | NTR6500 |
| Other | NL56370.058.15 : p16019 |