NCT04000126

Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Warmia and Mazury · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Pupil reflex dilation measurement (PRD)	Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
DEVICE	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
DRUG	Placebo	100ml 0,9% NaCl iv 10min before intubation
DEVICE	Bispectral Index (BIS)	Bispectral Index will be monitored to assess the depth of anaesthesia
DEVICE	HR	HR in beats/min will be measured by the electrocardiogram monitor
DEVICE	BP	BP will be measured automatically by an occluding upper arm cuff

Timeline

• Start date: 2019-02-25
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2019-06-27
• Last updated: 2020-01-22

Locations

1 site across 1 country: Poland