Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

Pain Clinical Trial

Official title:

Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000126
• Other study ID #: UWarmiaMazury
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: University of Warmia and Mazury
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Unconsciousness

Intervention

Device:
• Pupil reflex dilation measurement (PRD)
Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
• PPI (Pupillary Pain Index)
Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation

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

Device:
• Bispectral Index (BIS)
Bispectral Index will be monitored to assess the depth of anaesthesia
• HR
HR in beats/min will be measured by the electrocardiogram monitor
• BP
BP will be measured automatically by an occluding upper arm cuff

Locations

Country	Name	City	State
Poland	Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital	Olsztyn	Warmian-masurian

Sponsors (1)

Lead Sponsor	Collaborator
University of Warmia and Mazury

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	PRD: during the exact time of intubation (continuous measurement for 60 seconds)
Secondary	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)	HR - baseline and 0,1,2,3,4 minutes post-intubation
Secondary	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)	BP - baseline and 0,1,2,3,4 minutes post-intubation
Secondary	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.	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
Secondary	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).	5 minutes post-intubation