Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544980
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In our study the investigators sought to answer the question of how the retroglossal pharyngeal areas measured after extubation of patients compare to baseline before muscle relaxation values The investigators also investigated how these areas change as a function of TOF ratios measured at extubation thus looking for a correlation between residual muscle relaxant effect and airway area
Detailed Description:
Introduction
Postoperative residual neuromuscular can cause severe respiratory complications One of these is pharyngeal dilator muscle weakness which can lead to airway obstruction One way to prevent this is to have objective neuromuscular monitors to track the degree of muscle relaxation and use the measurements to guide the the suspension of neuromuscular block Monitoring the muscle relaxant effect is not a mandatory component of anaesthesia and is therefore often omitted in anaesthesiologists In our study the investigators investigated whether at the end of surgery only patients extubated at the end of surgery based on clinical signs have an airway diameter reduction and how this relates to the degree of residual muscle relaxation Our single-centre prospective study included 20 patients The patients narcosis by the anaesthetist as is often done in routine anaesthesia work is without monitoring neuromuscular block and on the basis of clinical signs deciding on extubation
Sample size calculation
In a previous study Eikermann and associates Eikermann M Vogt FM Herbstreit F Vahid-Dastgerdi M Zenge MO Ochterbeck C de Greiff A Peters J The predisposition to inspiratory upper airway collapse during partial neuromuscular blockade Am J Respir Crit Care Med 200717519-15 using MRI technique described a minimal retroglossal diameter after a total neuromuscular recovery of 20252 mm and a 20 decrease of this diameter at TOFR08 the investigators hypothesised that in the present study the decrease of the retroglossal cross-section area during inspiration will decrease by 30 in patients with residual neuromuscular block of any severity Using and alpha of 005 and a power of 90 8 patients were calculated to be necessary to prove our hypothesis In a previous study it was found that in our working group the amount of residual neuromuscular block as defined TOFR lt90 during spontaneous recovery at the end of surgery approximates 45 of all cases Nemes R Fülesdi B Pongrácz A Asztalos L Szabó- Maák Z Lengyel S Tassonyi E Impact of reversal strategies on the incidence of postoperative residual paralysis after rocuronium relaxation without neuromuscular monitoring A partially randomised placebo controlled trial Eur J Anaesthesiol 2017349609-616 With respect to this the investigators planned to include 18 patients the investigators also calculated with eventual dropouts and finally included 20 patients
Procedure of the investigation
During the operation the anaesthetist will routinely administer anaesthesia including the selection of muscle relaxant and the timing of extubation The latter is based solely on clinical signs and the anaesthetist performing narcosis does not use a neuromuscular monitor However the patients are not left without monitoring of the effect of the muscle relaxant as an independent anaesthesiologist performs continuous electromyographic neuromuscular monitoring of the anaesthetised patients the actual values of which are not known to the anaesthetist
Medication of the patient surgical procedure
As part of the balanced anaesthesia routinely used at the institute the patient is first premedicated with 75 mg midazolam 60 minutes before the onset of anaesthesia A peripheral vein is secured in one arm of the patient and infusion with Ringers lactate solution is started The other arm is left completely free for the independent anaesthetist on which neuromuscular monitoring is performed throughout the operation Continuous monitoring of the patients physiological parameters is ensured by the use of precordial ECG pulse oximetry blood pressure measurement central body temperature measurement end-expiratory oxygen and CO2 measurement throughout the duration of the operation
Induction of anaesthesia and maintenance of narcosis is achieved with total intravenous anaesthesia propofol anaesthesia TCI perfusion using the Schnider model During induction the propofol plasma concentration is set at 4-6 microgramsml Before the administration of opioids and muscle relaxants a control pharyngoscopy is performed at which time the BIS index ranges between 60-70 Patients are then asleep but spontaneous breathing is maintained Once the recording is complete the patient is given the type and dose of muscle relaxant chosen by the anaesthetist fentanyl is administrated and the anethesist intubate the trachea Subsequently anaesthesia is deepened for the duration of the operation with a BIS index of between 40-60 The target concentration is then changed to 25-4 µgml to maintain narcosis At the end of the operation the non-monitoring anaesthetist performing the anaesthesia extubates the patient by observing the clinical signs at which time the independent anaesthetist records the TOF value at the time of extubation Fentanyl is antagonised while the patient is asleep Pharyngoscopy is performed on the extubated patient If necessary ie when the TOF rate is below 90 rescue medication is administered
Neuromuscular monitoring
The anaesthetist did not monitor the patient but the independent anaesthetist monitored the effects of the muscle relaxant throughout the operation To do this he uses a Tetragraph electromyograph which stimulates the ulnar nerve and detects the direct action potential of the adductor pollicis muscle The application of the measuring instrument is facilitated by self-adhesive electrodes the stimulating electrodes are placed on the volar surface of the wrist according to the course of the nerve mentioned above and the sensing electrodes are placed towards the adductor pollicis muscle The device is started with the patient already asleep thus avoiding any discomfort due to stimulation Once started the device performs an autocalibration to determine the supramaximal excitation current to ensure muscle contraction The electromyography uses the train of four -TOF stimulation pattern
Offline analysis of pharnygoscopy and airway areas
During the examination of a patient two pharyngoscopies are performed The first one called control pharnygoscopy is performed under propofol but before the administration of opioid and muscle relaxant to ensure that the patient is breathing spontaneously This is also to exclude the negative effect of opiate analgesia on the pharyngeal muscles The second admission is performed after extubation During the pharnygoscopy a continuous chin lift Escmarch-Heiberg manoeuvre is used to guide the Ambu aScope 4 Rhino Laryngo Slim rhino-laryngoscope down the nose to the vocal cord The vocal fold was used as a landmark From here the camera was carefully retracted to locate the narrowest part of the pharynx which corresponded to the retroglossal region The found position is marked on the instrument with a marker making it easier to find the same part of the pharynx for the second recording During the pharyngoscopic examinations moving images were also taken during the inhalation and exhalation phases and these are analysed offline Using the online available software Image J Rasband WS US National Institutes of Health Bethesda Maryland USA httpsimagejnetij the size of the airway areas is determined in pixels From the resulting data set the investigators can compare the data from control and end-of-operation pharyngoscopies and subsequently perform statistical calculations Whenever possible the investigators use analysis of variance ANOVA to estimate the parametric tests Otherwise the non-parametric Kruskal-Wallis test is used to compare each group The significance level is defined as usual p005 Continuous variables are characterized by means and standard deviations
Rescue medication
After pharyngoscopy rescue medication is given if necessary ie below 90 TOF depending on the type of muscle relaxant used If an aminosteroid muscle relaxant is used the patient is given 2 mgkg sugammadex while if a benzylisoquinoline muscle relaxant is used 005 mgkg neostigmine and 0015 mgkg atropine are administrated to antagonise the drug effect
Postoperative residual neuromuscular can cause severe respiratory complications One of these is pharyngeal dilator muscle weakness which can lead to airway obstruction One way to prevent this is to have objective neuromuscular monitors to track the degree of muscle relaxation and use the measurements to guide the the suspension of neuromuscular block Monitoring the muscle relaxant effect is not a mandatory component of anaesthesia and is therefore often omitted in anaesthesiologists In our study the investigators investigated whether at the end of surgery only patients extubated at the end of surgery based on clinical signs have an airway diameter reduction and how this relates to the degree of residual muscle relaxation Our single-centre prospective study included 20 patients The patients narcosis by the anaesthetist as is often done in routine anaesthesia work is without monitoring neuromuscular block and on the basis of clinical signs deciding on extubation
Sample size calculation
In a previous study Eikermann and associates Eikermann M Vogt FM Herbstreit F Vahid-Dastgerdi M Zenge MO Ochterbeck C de Greiff A Peters J The predisposition to inspiratory upper airway collapse during partial neuromuscular blockade Am J Respir Crit Care Med 200717519-15 using MRI technique described a minimal retroglossal diameter after a total neuromuscular recovery of 20252 mm and a 20 decrease of this diameter at TOFR08 the investigators hypothesised that in the present study the decrease of the retroglossal cross-section area during inspiration will decrease by 30 in patients with residual neuromuscular block of any severity Using and alpha of 005 and a power of 90 8 patients were calculated to be necessary to prove our hypothesis In a previous study it was found that in our working group the amount of residual neuromuscular block as defined TOFR lt90 during spontaneous recovery at the end of surgery approximates 45 of all cases Nemes R Fülesdi B Pongrácz A Asztalos L Szabó- Maák Z Lengyel S Tassonyi E Impact of reversal strategies on the incidence of postoperative residual paralysis after rocuronium relaxation without neuromuscular monitoring A partially randomised placebo controlled trial Eur J Anaesthesiol 2017349609-616 With respect to this the investigators planned to include 18 patients the investigators also calculated with eventual dropouts and finally included 20 patients
Procedure of the investigation
During the operation the anaesthetist will routinely administer anaesthesia including the selection of muscle relaxant and the timing of extubation The latter is based solely on clinical signs and the anaesthetist performing narcosis does not use a neuromuscular monitor However the patients are not left without monitoring of the effect of the muscle relaxant as an independent anaesthesiologist performs continuous electromyographic neuromuscular monitoring of the anaesthetised patients the actual values of which are not known to the anaesthetist
Medication of the patient surgical procedure
As part of the balanced anaesthesia routinely used at the institute the patient is first premedicated with 75 mg midazolam 60 minutes before the onset of anaesthesia A peripheral vein is secured in one arm of the patient and infusion with Ringers lactate solution is started The other arm is left completely free for the independent anaesthetist on which neuromuscular monitoring is performed throughout the operation Continuous monitoring of the patients physiological parameters is ensured by the use of precordial ECG pulse oximetry blood pressure measurement central body temperature measurement end-expiratory oxygen and CO2 measurement throughout the duration of the operation
Induction of anaesthesia and maintenance of narcosis is achieved with total intravenous anaesthesia propofol anaesthesia TCI perfusion using the Schnider model During induction the propofol plasma concentration is set at 4-6 microgramsml Before the administration of opioids and muscle relaxants a control pharyngoscopy is performed at which time the BIS index ranges between 60-70 Patients are then asleep but spontaneous breathing is maintained Once the recording is complete the patient is given the type and dose of muscle relaxant chosen by the anaesthetist fentanyl is administrated and the anethesist intubate the trachea Subsequently anaesthesia is deepened for the duration of the operation with a BIS index of between 40-60 The target concentration is then changed to 25-4 µgml to maintain narcosis At the end of the operation the non-monitoring anaesthetist performing the anaesthesia extubates the patient by observing the clinical signs at which time the independent anaesthetist records the TOF value at the time of extubation Fentanyl is antagonised while the patient is asleep Pharyngoscopy is performed on the extubated patient If necessary ie when the TOF rate is below 90 rescue medication is administered
Neuromuscular monitoring
The anaesthetist did not monitor the patient but the independent anaesthetist monitored the effects of the muscle relaxant throughout the operation To do this he uses a Tetragraph electromyograph which stimulates the ulnar nerve and detects the direct action potential of the adductor pollicis muscle The application of the measuring instrument is facilitated by self-adhesive electrodes the stimulating electrodes are placed on the volar surface of the wrist according to the course of the nerve mentioned above and the sensing electrodes are placed towards the adductor pollicis muscle The device is started with the patient already asleep thus avoiding any discomfort due to stimulation Once started the device performs an autocalibration to determine the supramaximal excitation current to ensure muscle contraction The electromyography uses the train of four -TOF stimulation pattern
Offline analysis of pharnygoscopy and airway areas
During the examination of a patient two pharyngoscopies are performed The first one called control pharnygoscopy is performed under propofol but before the administration of opioid and muscle relaxant to ensure that the patient is breathing spontaneously This is also to exclude the negative effect of opiate analgesia on the pharyngeal muscles The second admission is performed after extubation During the pharnygoscopy a continuous chin lift Escmarch-Heiberg manoeuvre is used to guide the Ambu aScope 4 Rhino Laryngo Slim rhino-laryngoscope down the nose to the vocal cord The vocal fold was used as a landmark From here the camera was carefully retracted to locate the narrowest part of the pharynx which corresponded to the retroglossal region The found position is marked on the instrument with a marker making it easier to find the same part of the pharynx for the second recording During the pharyngoscopic examinations moving images were also taken during the inhalation and exhalation phases and these are analysed offline Using the online available software Image J Rasband WS US National Institutes of Health Bethesda Maryland USA httpsimagejnetij the size of the airway areas is determined in pixels From the resulting data set the investigators can compare the data from control and end-of-operation pharyngoscopies and subsequently perform statistical calculations Whenever possible the investigators use analysis of variance ANOVA to estimate the parametric tests Otherwise the non-parametric Kruskal-Wallis test is used to compare each group The significance level is defined as usual p005 Continuous variables are characterized by means and standard deviations
Rescue medication
After pharyngoscopy rescue medication is given if necessary ie below 90 TOF depending on the type of muscle relaxant used If an aminosteroid muscle relaxant is used the patient is given 2 mgkg sugammadex while if a benzylisoquinoline muscle relaxant is used 005 mgkg neostigmine and 0015 mgkg atropine are administrated to antagonise the drug effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None