Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

University of Warmia and Mazury1 site in 1 country90 target enrollmentFebruary 25, 2019

ConditionsPain

InterventionsPupil reflex dilation measurement (PRD)PPI (Pupillary Pain Index)Bispectral Index (BIS)HR BP Placebo lidocaine

Drugslidocaine Placebo

Overview

Phase: Not Applicable
Intervention: Pupil reflex dilation measurement (PRD)
Conditions: Pain
Sponsor: University of Warmia and Mazury
Enrollment: 90
Locations: 1
Primary Endpoint: Usefulness of Pupillary Reflex Dilation (PRD) measured using a video pupillometer in determining the role of lidocaine iv before intubation.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 25, 2019

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Warmia and Mazury

Responsible Party

Principal Investigator

Malgorzata Braczkowska

Principal Investigator

University of Warmia and Mazury

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

Intervention: Bispectral Index (BIS)

Placebo P

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

Intervention: HR

Placebo P

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

Intervention: BP

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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.(BP - baseline and 0,1,2,3,4 minutes post-intubation)
The influence of intravenous lidocaine on PPI(5 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)