Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

NCT ID: NCT04000126

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2019-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Control C

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

Group Type: ACTIVE_COMPARATOR

Pupil reflex dilation measurement (PRD)

Intervention Type: DEVICE

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

PPI (Pupillary Pain Index)

Intervention Type: DEVICE

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

Bispectral Index (BIS)

Intervention Type: DEVICE

Bispectral Index will be monitored to assess the depth of anaesthesia

HR

Intervention Type: DEVICE

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

BP

Intervention Type: DEVICE

BP will be measured automatically by an occluding upper arm cuff

Lignocaine group L

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

Group Type: EXPERIMENTAL

Pupil reflex dilation measurement (PRD)

Intervention Type: DEVICE

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

PPI (Pupillary Pain Index)

Intervention Type: DEVICE

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

lidocaine

Intervention Type: DRUG

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

Bispectral Index (BIS)

Intervention Type: DEVICE

Bispectral Index will be monitored to assess the depth of anaesthesia

HR

Intervention Type: DEVICE

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

BP

Intervention Type: DEVICE

BP will be measured automatically by an occluding upper arm cuff

Placebo P

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

Group Type: PLACEBO_COMPARATOR

Pupil reflex dilation measurement (PRD)

Intervention Type: DEVICE

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

PPI (Pupillary Pain Index)

Intervention Type: DEVICE

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

Placebo

Intervention Type: DRUG

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

Bispectral Index (BIS)

Intervention Type: DEVICE

Bispectral Index will be monitored to assess the depth of anaesthesia

HR

Intervention Type: DEVICE

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

BP

Intervention Type: DEVICE

BP will be measured automatically by an occluding upper arm cuff

Interventions

Pupil reflex dilation measurement (PRD)

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

Intervention Type: DEVICE

PPI (Pupillary Pain Index)

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

Intervention Type: DEVICE

lidocaine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Bispectral Index (BIS)

Bispectral Index will be monitored to assess the depth of anaesthesia

Intervention Type: DEVICE

HR

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

Intervention Type: DEVICE

BP

BP will be measured automatically by an occluding upper arm cuff

Intervention Type: DEVICE

Other Intervention Names

lidocaine, Xylocaine; 0,9% natrium chloratum, sodium chloride

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Warmia and Mazury

OTHER

Sponsor Role: lead

Responsible Party

Malgorzata Braczkowska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ewa Mayzner-Zawadzka, MD,PhD,Prof

Role: STUDY_CHAIR

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

Locations

Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Olsztyn, Warmian-Masurian Voivodeship, Poland

Countries

Poland

Other Identifiers

UWarmiaMazury

Identifier Type: -

Identifier Source: org_study_id