NOL-Guided vs Conventional Intraoperative Opioid Infusion on Outcomes in Geriatric Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-90
SponsorSaglik Bilimleri Universitesi

About this trial

The aim of this study is to compare the effects of conventional methods and goal-directed therapy guided by pain monitoring on total remifentanil dosage, wake-up time, and complications in geriatric patients undergoing lumbar stabilization surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing lumbar stabilization surgery

Disqualifiers

Chronic opioid use

Severe congestive heart failıure

Severe arrhythmia

Uncontrolled hypertension

Trial population

A total of 80 geriatric patients undergoing lumbar stabilization surgery

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • nociceptive level

    Device

    remifentanil infusion dose adjustment according to the changes of nociceptive level

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Conservative0 interventions
Group B: Nociceptive level1 intervention

Trial outcomes

Primary outcomes

1

Total dose

Total dose of remifentanil used in operation

Time frame
operation duration

Secondary outcomes

1

postoperative pain

pain evaluation during postoperative 24 hour, 11 point Numeric Rating Scale (NRS) will be used to measure pain level (0-10) 0: No pain, 10: Worst possible pain

Time frame
postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours
2

nausea and vomiting

postoperative nausea and vomiting Nausea-vomiting will be assessed using a 4-point scale: 0: none 1. nausea without vomiting 2. nausea with vomiting 3. vomiting more than twice

Time frame
postoperative 10th, 20th, and 30th minutes, 1, 3, 6, and 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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