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Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pupil reflex dilation measurement (PRD)
PPI (Pupillary Pain Index)
lidocaine
Placebo
Bispectral Index (BIS)
HR
BP
Sponsored by
University of Warmia and Mazury
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain focused on measuring lidocaine, intubation, pupillometry, hemodynamic response, pain, reflex, pupillary monitoring, intraoperative, analgesia, general anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Patients who are taking drugs influencing the pupil size
  • Patients with pacemaker
  • Patients younger than 18 years of age
  • History of chronic pain, chronic opioid use (> 3 months)

Sites / Locations

  • Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Control C

Lignocaine group L

Placebo P

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The influence of intravenous lidocaine on level of analgesia during orotracheal intubation
Changes that occur in PRD measured using video pupillometer as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control).
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring changes in HR (beats/min)
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring changes in BP (mmHg)
Correlation between PRD and PPI (Pupillary Pain Index) measured using video pupillometer and BIS (Bispectral Index)
Changes that occur in PRD and PPI as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control) and correlated to BIS in all groups.
The influence of intravenous lidocaine on PPI
Changes that occur in PPI measure using video pupillometer as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control).

Full Information

First Posted
May 1, 2019
Last Updated
January 17, 2020
Sponsor
University of Warmia and Mazury
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1. Study Identification

Unique Protocol Identification Number
NCT04000126
Brief Title
Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
Official Title
Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Laryngoscopy and tracheal intubation are associated with a sympathetic discharge caused by stimulation of the upper respiratory tract. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation. Hemodynamic response might be masked by the drugs the patient is taking and its status (ex. sepsis). There's a need for an objective pain assessment method while the patient is unconscious, to maintain a proper level of analgesia and to control the hemodynamic response in order to decrease systemic repercussions. This single-blind, randomized, single center, prospective study was approved by the Bioethics Committee of the University of Warmia and Mazury under the report number 11/2019 21st of February 2019. Patients scheduled for elective surgery under general anesthesia with tracheal intubation were divided into three groups: Group 1: anaesthetic induction with standard doses iv was performed (fentanyl 3mcg/kg, propofol 2mg/kg, rocuronium 0,6mg/kg). Group 2: same as in group 1 + lidocaine 1,5mg/kg w 100ml 0,9% NaCl 10 min before intubation. Group 3 (placebo group): same as group 1 + 100ml 0,9% NaCl 10 min before intubation The values for blood pressure (NIBP), heart rate (HR), Train of four (TOF) and bispectral index (BIS) were measured in all groups during the whole time of the protocol. PRD (Pupillary Reflex Dilation) was measured in the exact time of intubation. Additionally, after intubation PPI (Pupillary Pain Index) was checked. During the whole protocol BIS value was maintained to be equal to or less than 50, if this value was not reached, a venous increment of 1mg/kg of propofol was administered. Hypertension was considered when the BP values were 20% above baseline values or if Systolic Blood Pressure (SBP) > 140 mmHg. Hypotension was considered when the Blood Pressure (BP) values were 20% below baseline values or if SBP > 90 mmHg. Tachycardia was considered when the Heart Rate (HR) values were 20% above baseline values or if HR > 100 mmHg. Bradycardia was considered for HR values under 50 bpm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
lidocaine, intubation, pupillometry, hemodynamic response, pain, reflex, pupillary monitoring, intraoperative, analgesia, general anesthesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control C
Arm Type
Active Comparator
Arm Description
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
Arm Title
Lignocaine group L
Arm Type
Experimental
Arm Description
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
Arm Title
Placebo P
Arm Type
Placebo Comparator
Arm Description
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
Intervention Type
Device
Intervention Name(s)
Pupil reflex dilation measurement (PRD)
Intervention Description
Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
Intervention Type
Device
Intervention Name(s)
PPI (Pupillary Pain Index)
Intervention Description
Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation
Intervention Type
Drug
Intervention Name(s)
lidocaine
Other Intervention Name(s)
lidocaine, Xylocaine
Intervention Description
1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0,9% natrium chloratum, sodium chloride
Intervention Description
100ml 0,9% NaCl iv 10min before intubation
Intervention Type
Device
Intervention Name(s)
Bispectral Index (BIS)
Intervention Description
Bispectral Index will be monitored to assess the depth of anaesthesia
Intervention Type
Device
Intervention Name(s)
HR
Intervention Description
HR in beats/min will be measured by the electrocardiogram monitor
Intervention Type
Device
Intervention Name(s)
BP
Intervention Description
BP will be measured automatically by an occluding upper arm cuff
Primary Outcome Measure Information:
Title
Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.
Description
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).
Time Frame
PRD: during the exact time of intubation (continuous measurement for 60 seconds)
Secondary Outcome Measure Information:
Title
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation
Description
Changes that occur in PRD measured using video pupillometer as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control).
Time Frame
PRD: during the exact time of intubation (continuous measurement for 60 seconds)
Title
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Description
Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring changes in HR (beats/min)
Time Frame
HR - baseline and 0,1,2,3,4 minutes post-intubation
Title
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Description
Level of analgesia will be investigated in all groups (placebo, lidocaine, control) basing on the autonomous system activation during intubation by measuring changes in BP (mmHg)
Time Frame
BP - baseline and 0,1,2,3,4 minutes post-intubation
Title
Correlation between PRD and PPI (Pupillary Pain Index) measured using video pupillometer and BIS (Bispectral Index)
Description
Changes that occur in PRD and PPI as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control) and correlated to BIS in all groups.
Time Frame
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
Title
The influence of intravenous lidocaine on PPI
Description
Changes that occur in PPI measure using video pupillometer as a response to an analgesic intervention will be investigated in all groups (placebo, lidocaine, control).
Time Frame
5 minutes post-intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical State 1 or 2 of the American Society of Anesthesiology (ASA) Electively scheduled for surgery requiring general anesthesia Age >18 years Exclusion Criteria: 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 Patients who are taking drugs influencing the pupil size Patients with pacemaker Patients younger than 18 years of age History of chronic pain, chronic opioid use (> 3 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Mayzner-Zawadzka, MD,PhD,Prof
Organizational Affiliation
Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury
Official's Role
Study Chair
Facility Information:
Facility Name
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
City
Olsztyn
State/Province
Warmian-masurian
ZIP/Postal Code
11-041
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified study participants data for all primary and secondary outcome measures.
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing 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.

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Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

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