ociceptive-Level (NoL)-guided analgesia versus standard practice during general remifentanil/propofol anesthesia in ASA 1-3 patients

Phase 2

Completed

Conditions: anesthesie/chirurgie
anesthesia
narcosis

Registration Number: NL-OMON42622

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Opioid and propofol consumption in total dose and dose/min; and<br /><br>2. Incidence (number of episodes) and total duration of inadequate anesthesia<br /><br>(as derived from heart rate, blood pressure, BIS values and somatic arousal)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Differences in Pk (prediction probability) values of NoL, BIS, HR and MAP<br /><br>for predicting the balance of nociception-anti nociception during the following<br /><br>states<br /><br>• Awake vs. loss of consiousness (LOC)<br /><br>• Anesthesia (after discontinuation of propofol and remifentanil) vs. opening<br /><br>eyes<br /><br>• LOC vs intubation<br /><br>• Normal stimulation vs maximum stimulation (as indicated by the surgeon);<br /><br>2. Incidence of NoL values < 10 and > 20;<br /><br>3. Time from reversal of neuromuscular blockade to extubation;<br /><br>4. Pain and sedation scores, incidence of nausea/vomiting, hemodynamics,<br /><br>respiration and medication use (e.g. opioids and antiemetics) in the recovery<br /><br>room obtained at 15-min interval;<br /><br>5. PACU: time until Aldrete > 9 (readiness for discharge);<br /><br>6. Incidence of memory/awareness.</p><br>