Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Device: Pupil reflex dilation measurement (PRD) Device: PPI (Pupillary Pain Index) Drug: lidocaine Drug: Placebo Device: Bispectral Index (BIS) Device: HR Device: BP | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious |
Actual Study Start Date : | February 25, 2019 |
Actual Primary Completion Date : | November 30, 2019 |
Actual Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Control C
This group will be given induction anesthesia agents in standard doses (fentanyl 3mcg/kg, propofol 2mg/ kg, rocuronium 0,6mg/kg)
|
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
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
|
Experimental: Lignocaine group L
This group will be given additionally 1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
|
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
Other Name: lidocaine, Xylocaine
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
|
Placebo Comparator: Placebo P
This group will be given additionally 100 ml 0,9% NaCl iv 10 min before intubation
|
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: Placebo 100ml 0,9% NaCl iv 10min before intubation
Other Name: 0,9% natrium chloratum, sodium chloride
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
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital | |
Olsztyn, Warmian-masurian, Poland, 11-041 |
Study Chair: | Ewa Mayzner-Zawadzka, MD,PhD,Prof | Anesthesiology and Intensive Care Clinical Ward, University of Warmia and Mazury |
Tracking Information | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 1, 2019 | ||||||||||||||||
First Posted Date ICMJE | June 27, 2019 | ||||||||||||||||
Last Update Posted Date | January 22, 2020 | ||||||||||||||||
Actual Study Start Date ICMJE | February 25, 2019 | ||||||||||||||||
Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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).
|
||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious | ||||||||||||||||
Official Title ICMJE | Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious | ||||||||||||||||
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. |
||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Diagnostic |
||||||||||||||||
Condition ICMJE | Pain | ||||||||||||||||
Intervention ICMJE |
|
||||||||||||||||
Study Arms ICMJE |
|
||||||||||||||||
Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
90 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Actual Study Completion Date ICMJE | December 31, 2019 | ||||||||||||||||
Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Poland | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04000126 | ||||||||||||||||
Other Study ID Numbers ICMJE | UWarmiaMazury | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||||
Responsible Party | Malgorzata Braczkowska, University of Warmia and Mazury | ||||||||||||||||
Study Sponsor ICMJE | University of Warmia and Mazury | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
|
||||||||||||||||
PRS Account | University of Warmia and Mazury | ||||||||||||||||
Verification Date | January 2020 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |