PainNCT04000126
Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
A study testing Pupil reflex dilation measurement (PRD), PPI (Pupillary Pain Index) and lidocaine in people with Pain, run by University of Warmia and Mazury at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pupil reflex dilation measurement (PRD), PPI (Pupillary Pain Index) and lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 25 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical State 1 or 2 of the American Society of Anesthesiology (ASA)
- Electively scheduled for surgery requiring general anesthesia
- Age >18 years
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
Olsztyn, Warmian-Masurian Voivodeship, 11-041
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Pupil reflex dilation measurement (PRD), PPI (Pupillary Pain Index), lidocaine, Placebo, Bispectral Index (BIS)
- Keywords
- lidocaine, intubation, pupillometry, hemodynamic response, pain, reflex, pupillary monitoring, intraoperative, analgesia, general anesthesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupil reflex dilation measurement (PRD)Device
Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
PPI (Pupillary Pain Index)Device
Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation
lidocaineDrug
Also called lidocaine, Xylocaine
1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
PlaceboDrug
Also called 0,9% natrium chloratum, sodium chloride
100ml 0,9% NaCl iv 10min before intubation
Bispectral Index (BIS)Device
Bispectral Index will be monitored to assess the depth of anaesthesia
HRDevice
HR in beats/min will be measured by the electrocardiogram monitor
BPDevice
BP will be measured automatically by an occluding upper arm cuff
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: Device: Pupil reflex dilation measurement (PRD); Device: PPI (Pupillary Pain Index); Drug: Placebo; Device: Bispectral Index (BIS); Device: HR; Device: BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: PRD: during the exact time of intubation (continuous measurement for 60 seconds)
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)
Measured: HR - baseline and 0,1,2,3,4 minutes post-intubation
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)
Measured: 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)
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.
Measured: 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
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).
Measured: 5 minutes post-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start25 Feb 2019
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malgorzata Braczkowska, University of Warmia and Mazury
- Investigators
- Ewa Mayzner-Zawadzka, MD,PhD,Prof, Study chair, Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000126
- Sponsor's protocol ID
- UWarmiaMazury
- Status last verified
- Jan 2020
- First submitted
- 1 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study participants data for all primary and secondary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious
- ClinicalTrials.gov ID
- NCT04000126
- Acronym / sponsor ID
- UWarmiaMazury
- Conditions
- Pain
- Keywords
- lidocaine, intubation, pupillometry, hemodynamic response, pain, reflex, pupillary monitoring, intraoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control C | Active comparator | Device: Pupil reflex dilation measurement (PRD), Device: PPI (Pupillary Pain Index), Device: Bispectral Index (BIS), Device: HR, Device: BPThis group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg) |
| Lignocaine group L | Experimental | Device: Pupil reflex dilation measurement (PRD), Device: PPI (Pupillary Pain Index), Drug: lidocaine, Device: Bispectral Index (BIS), Device: HR, Device: BPThis group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation |
| Placebo P | Placebo comparator | Device: Pupil reflex dilation measurement (PRD), Device: PPI (Pupillary Pain Index), Drug: Placebo, Device: Bispectral Index (BIS), Device: HR, Device: BPThis group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physical State 1 or 2 of the American Society of Anesthesiology (ASA)
- Electively scheduled for surgery requiring general anesthesia
- Age >18 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupil reflex dilation measurement (PRD)Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer | Device | Control C, Lignocaine group L, Placebo P |
| PPI (Pupillary Pain Index)Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation | Device | Control C, Lignocaine group L, Placebo P |
| lidocaineAlso: lidocaine, Xylocaine1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation | Drug | Lignocaine group L |
| PlaceboAlso: 0,9% natrium chloratum, sodium chloride100ml 0,9% NaCl iv 10min before intubation | Drug | Placebo P |
| Bispectral Index (BIS)Bispectral Index will be monitored to assess the depth of anaesthesia | Device | Control C, Lignocaine group L, Placebo P |
| HRHR in beats/min will be measured by the electrocardiogram monitor | Device | Control C, Lignocaine group L, Placebo P |
| BPBP will be measured automatically by an occluding upper arm cuff | Device | Control C, Lignocaine group L, Placebo P |
Primary outcome
Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.
Time frame: PRD: during the exact time of intubation (continuous measurement for 60 seconds)
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).
5 secondary outcomes
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation
Time frame: PRD: during the exact time of intubation (continuous measurement for 60 seconds)
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Time frame: HR - baseline and 0,1,2,3,4 minutes post-intubation
The influence of intravenous lidocaine on level of analgesia during orotracheal intubation.
Time frame: 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)
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
The influence of intravenous lidocaine on PPI
Time frame: 5 minutes post-intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Yes. De-identified study participants data for all primary and secondary outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Mayzner-Zawadzka, MD,PhD,Prof study chair
Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupil reflex dilation measurement (PRD), PPI (Pupillary Pain Index) and lidocaine in people with Pain, run by University of Warmia and Mazury at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation. (time frame: PRD: during the exact time of intubation (continuous measurement for 60 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.