Health TrialsbyHealthPanel

NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia

ConditionIntraoperative Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAttikon Hospital

About this trial

The aim of this study is to investigate the hypothesis that the intraoperative use of the nociception level index NOL can reduce opioid consumption in adult patients undergoing elective laparoscopic surgeries under general anesthesia, as well as to explore its effect on post-operative pain and patient recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients undergoing planned laparoscopic surgery under general anesthesia.

Disqualifiers

Emergency surgery.

Pregnancy.

Drug or alcohol abuse in the last 6 months.

Chronic opioid use or patients with chronic pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nociception level index (NOL™)

    Device

    If a NOL value \>25 persists for \>1 minute a bolus of iv fentanyl 0.5mcg/kg will be given and reassessment of the NOL value will continue every 5 minutes. If NOL index value: 10-25 is not reached within 10 minutes, fentanyl 0.5mcg/kg iv is re-administered.

  • Fentanyl

    Other intervention

    Bolus doses of iv fentanyl 0.5 mcg/kg will be administered based on the judgment of the anesthesiologist in charge.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Nociception level index (NOL™)Active comparator 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative total consumption of opioids

Intraoperative total consumption of opioids will be calculated in all patients.

Time frame
Up to 30 minutes after the end of operation

Secondary outcomes

1

Postoperative administration of opioids in PACU

Total consumption of opioids will be calculated in all patients

Time frame
Until the patient is released from PACU (up to 24 hours)
2

Intensity of postoperative pain in PACU

In PACU, intensity of postoperative pain will be assessed every 15 minutes with the Visual analogue scale, a 10 points scale (0= no pain and 10= worst pain)

Time frame
Until the patient is released from PACU (up to 24 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Attikon Hospital

Lead sponsor

Source ClinicalTrials.gov
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