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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

Recruiting
Conditions
Surgical patients
Registration Number
NL-OMON29352
Lead Sponsor
MC
Brief Summary

A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
50
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

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 systolic blood pressure > 160 mmHg)
7.Preoperative Heart rate < 45/min or > 90/min;
8.Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Postoperative pain score
Secondary Outcome Measures
NameTimeMethod
(!) Postoperative opioid consumption as measured in the first 90 min of PACU stay<br>(2) Fentanyl use during anesthesia;<br>(3) Sevoflurane consumption during anesthesia;<br>(4) Inadequate hemodynamic events, see Table 1;<br>(5) Time between reversal of neuromuscular block and extubation/eyes open;<br>(6) Occurrence of awareness;<br>(7) Anesthesia and surgery times/PACU stay time.<br>
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