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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42622

Enrollment

Registered

2016-05-12

Start date

2016-07-25

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anesthesie/chirurgie anesthesia narcosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-80 years; 2. ASA I-II-III 3. Elective open abdominal surgery or laparoscopic assisted abdominal surgery.

Exclusion criteria

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 100 mmHg) 7. Preoperative Heart rate 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 6.0 kPa c. Significant hepatic disease with increased bilirubin, INR or low albumin 13. Beta blocker use

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

—

Countries

Netherlands

Outcome results