Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

NCT04000126 | Completed DMC

• 1 other identifier: UWarmiaMazury
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the usefulness of pupillometry as a nociceptive indicator during elective orotracheal intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation.

Conditions

Pain

Keywords

lidocaine; intubation; pupillometry; hemodynamic response; pain; reflex; pupillary monitoring; intraoperative; analgesia; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.

  Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring variation of pupil diameter (% and mm).

  PRD: during the exact time of intubation (continuous measurement for 60 seconds)

Secondary Outcomes (5)

• The influence of intravenous lidocaine on level of analgesia during orotracheal intubation

  PRD: during the exact time of intubation (continuous measurement for 60 seconds)

• The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.

  HR - baseline and 0,1,2,3,4 minutes post-intubation

• The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.

  BP - baseline and 0,1,2,3,4 minutes post-intubation

• Correlation between PRD and PPI (Pupillary Pain Index) measured using video pupillometer and BIS (Bispectral Index)

  BIS - baseline, during intubation, 0,1,2,3,4,5 minutes post-intubation, PRD: during the exact time of intubation (continuous measurement for 60 seconds), PPI - 5 minutes post-intubation

• The influence of intravenous lidocaine on PPI

  5 minutes post-intubation

Study Arms (3)

Control C

ACTIVE COMPARATOR

This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)

Device: Pupil reflex dilation measurement (PRD); Device: PPI (Pupillary Pain Index); Device: Bispectral Index (BIS); Device: HR; Device: BP

Lignocaine group L

EXPERIMENTAL

This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation

Device: Pupil reflex dilation measurement (PRD); Device: PPI (Pupillary Pain Index); Drug: lidocaine; Device: Bispectral Index (BIS); Device: HR; Device: BP

Placebo P

PLACEBO COMPARATOR

This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation

Device: Pupil reflex dilation measurement (PRD); Device: PPI (Pupillary Pain Index); Drug: Placebo; Device: Bispectral Index (BIS); Device: HR; Device: BP

Interventions

Pupil reflex dilation measurement (PRD) DEVICE

Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer

Control C; Lignocaine group L; Placebo P

PPI (Pupillary Pain Index) DEVICE

Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation

Control C; Lignocaine group L; Placebo P

lidocaine DRUG

1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation

Also known as: lidocaine, Xylocaine

Lignocaine group L

Placebo DRUG

100ml 0,9% NaCl iv 10min before intubation

Also known as: 0,9% natrium chloratum, sodium chloride

Placebo P

Bispectral Index (BIS) DEVICE

Bispectral Index will be monitored to assess the depth of anaesthesia

Control C; Lignocaine group L; Placebo P

HR DEVICE

HR in beats/min will be measured by the electrocardiogram monitor

Control C; Lignocaine group L; Placebo P

BP DEVICE

BP will be measured automatically by an occluding upper arm cuff

Control C; Lignocaine group L; Placebo P

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical State 1 or 2 of the American Society of Anesthesiology (ASA)
• Electively scheduled for surgery requiring general anesthesia
• Age \>18 years

You may not qualify if:

• Difficult airway
• Unanticipated difficult airway based on the previous history of difficult intubation
• Urgently scheduled for surgery requiring general anesthesia
• Ophthalmologic pathology precluding pupillometry, ex. Horner's syndrome, Sjogrens syndrome
• Anisocoria
• History of opioid abuse
• Subjects who are or may be pregnant
• Unable to converse in Polish
• History of psychiatric/cognitive disease
• Patients who do not give informed consent
• Patients with contraindications or history of hypersensitivity to lidocaine
• Patients with coronary ischemic disease
• Patients with atrioventricular block at any grade
• Patients with diagnosed cardiac arrhythmias
• Patients with heart failure

Sponsors & Collaborators

• University of Warmia and Mazury: lead

Study Sites (1)

Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine; Sodium Chloride; Consciousness Monitors

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Surgical Equipment; Equipment and Supplies

Study Officials

• Ewa Mayzner-Zawadzka, MD,PhD,Prof

  Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: June 27, 2019
• Study Start: February 25, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 12 months of study completion
• Access Criteria: Data will be made available for researchers who provide a methodologically sound proposal. Proposals should be directed to m.braczkowska@gmail.com . Data access requests will be reviewed by an External Independent Review Panel. To gain access, data requestors will need to sign a data access agreement.

Locations

PL (1)