Monitoring Pupillary Reflex Dilatation for Optimized Postoperative Opioid Delivery Before Extubation.

NCT04594382 | Completed

• 1 other identifier: 2063/2020
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be designed to investigate the effect of pupillometry guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery before extubation, on total postoperative opioid consumption during the first 2 postoperative hours after elective ear nose throat (ENT) surgery.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Infrared Pupillometry; Postoperative Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  cumulative opioid consumption within first 2 postoperative hours

  first 2 postoperative hours

Secondary Outcomes (1)

• postoperative pain intensity

  first 2 postoperative hours

Study Arms (3)

T30/60

ACTIVE COMPARATOR

Before extubation, opioid administration will be given by a single dose of opioids in case of measured PDR values of ≥12.

Diagnostic Test: Pupillometry-Opioid treatment

Non-T30/60

ACTIVE COMPARATOR

A standardized single dose of opioid will be given intravenously before extubation, regardless of the measured pupillometry PDR values.

Diagnostic Test: Pupillometry -standardized opioid treatment

Standard Care group

NO INTERVENTION

The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant.

Interventions

Pupillometry-Opioid treatment DIAGNOSTIC_TEST

At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer. Opioid administration will be given by a single dose of piritramid (0.1 mg kg -1) in case of measured PDR values of ≥12 (high analgesic sensitivity as specified by the producer) after T30 and T60 stimulation. The pupillometry measurement will be repeated once on both eyes.

T30/60

Pupillometry -standardized opioid treatment DIAGNOSTIC_TEST

At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer. A standardized single dose of piritramid (0,1 mg kg -1) will be given intravenously, regardless of the measured values. The pupillometry measurement will be repeated once on both eyes.

Non-T30/60

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) physical status I-II
• able to read and understand the information sheet and to sign the consent form
• being scheduled for elective ENT surgery under general anesthesia
• age≥18 years

You may not qualify if:

• ASA physical status of III and above
• previous history of either drug or alcohol abuse
• difficulty to understand pain scoring system
• chronic users of analgesics or had used opioids within 12 h before surgery
• drug or alcohol abuse
• contraindications for metamizole
• preoperative topical eye medication (atropine, phenylephrine), preoperative pupil abnormality
• concomitant treatment with beta-antagonists, metoclopramide or droperidol
• implanted electronic medical devices
• dysfunction of the autonomic nervous system in relation to advanced diabetes mellitus
• ophthalmologic diseases, known pupil reflex disorders, cranial nerve lesions
• rapid sequence induction (RSI)
• neurological, psychiatric or mental disorders
• surgical procedure warranting elective postoperative ventilation

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: October 21, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)