Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland
NCT Number: NCT04000126
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation
1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
Other names: lidocaine, Xylocaine
100ml 0,9% NaCl iv 10min before intubation
Other names: 0,9% natrium chloratum, sodium chloride
Bispectral Index will be monitored to assess the depth of anaesthesia
HR in beats/min will be measured by the electrocardiogram monitor
BP will be measured automatically by an occluding upper arm cuff
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).
Time frame: PRD: during the exact time of intubation (continuous measurement for 60 seconds)
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).
Time frame: HR - baseline and 0,1,2,3,4 minutes post-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)
Time frame: BP - baseline and 0,1,2,3,4 minutes post-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)
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
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.
Time frame: 5 minutes post-intubation
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).
University of Warmia and Mazury
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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