FindTrial
Sign In

Sevoflurane/fentanyl anesthesia guided by Nociceptive-Level index during abdominal surgery in ASA 1-3 patients – a randomized controlled trial on the effect of NOL-guidance on postoperative pain scores

Sevoflurane/fentanyl anesthesia guided by Nociceptive-Level index during abdominal surgery in ASA 1-3 patients – a randomized controlled trial on the effect of NOL-guidance on postoperative pain scores

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29352
Enrollment
50
Registered
2019-06-28
Start date
2019-06-28
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Surgical patients

Interventions

This is a double blind, randomized controlled superiority trial in which NOL-guided anesthesia will be compared to standard of care in ASA 1-3 patients undergoing elective open abdominal surgery or la

Sponsors

LUMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18 years and older; 2. ASA I-II-III 3. Elective open abdominal surgery or robot/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 160 mmHg) 7. Preoperative Heart rate 90/min; 8. Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures);

Design outcomes

Primary

MeasureTime frame
Postoperative pain score—

Secondary

MeasureTime frame
(!) Postoperative opioid consumption as measured in the first 90 min of PACU stay (2) Fentanyl use during anesthesia; (3) Sevoflurane consumption during anesthesia; (4) Inadequate hemodynamic events, see Table 1; (5) Time between reversal of neuromuscular block and extubation/eyes open; (6) Occurrence of awareness; (7) Anesthesia and surgery times/PACU stay time.—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center

a.dahan@lumc.nl0715262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)