An interventional study of 10% lidocaine spray and Placebo of lidocaine spray in Anesthesia, General, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other
Laryngeal mask airway (LMA) is currently the most widely used supraglottic airway device with advantages of simple and fast placement, reduced anesthesia drug use, more stable hemodynamics, and less throat discomfort after anesthesia compared to endotracheal intubation. Some studies claimed the use of muscle relaxants or local anesthetics (sprays or lubricants containing local anesthetics) for the throat before LMA placement can reduce the dosage of induction agents and postoperative throat complications.
In modern society, more and more elderly people undergo elective surgery with the need of general anesthesia. However, they are the more vulnerable population with tendency of greater hemodynamic changes with more induction agent usage. Propofol is one of the most used induction agents which may lead to a drop in blood pressure. The objective of this study is to observe whether the dose of propofol and the changes in hemodynamics can be reduced by using muscle relaxants or laryngeal local anesthetics in elderly who receiving general anesthesia with LMA insertion.
64 studies on the registry are indexed under Muscle Hypotonia; 15 are open to participants now.
This study's enrollment of 96 is above the median of 60 across 45 interventional studies indexed under Muscle Hypotonia.
Browse Muscle Hypotonia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
Drug: 10% lidocaine spray · Drug: Cisatracurium · Drug: Propofol
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1.25 mg/kg.
Drug: 10% lidocaine spray · Drug: Placebo of cisatracurium · Drug: Propofol
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
Drug: Placebo of lidocaine spray · Drug: Cisatracurium · Drug: Propofol
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 2 mg/kg.
Drug: Placebo of lidocaine spray · Drug: Placebo of cisatracurium · Drug: Propofol
10% lidocaine spray 3 puff for the throat before induction
Normal saline spray 3 puff for the throat before induction
Intravenous cisatracurium 0.12 mg/kg during induction
Intravenous normal saline during induction
The dosage of intravenous propofol for the first subjects was predetermined for each arm, and the dosage for the subsequent subjects would be determined according to the response of the previous subjects using the Dixon's up-and-down method with a step size of 0.25 mg/kg. If the subjects had no movement and stable hemodynamic status during and after the laryngeal mask airway (LMA) placement, the predetermined dosage of propofol for the subsequent subject would be decreased by 0.25 mg/kg. On the other hand, if the subjects had obvious movement, failure to LMA placement, and significant hemodynamic changes, the predetermined dosage of propofol for the subsequent subject would be increased by 0.25 mg/kg.
Propofol requirement
The minimal propofol requirement dose was defined as the median effective dose (ED50) of movement or increased mean arterial pressure (MAP) to no movement or stable MAP. The ED50 is the average of the crossover midpoints found during conducting the Dixon's up-and-down method.
Time frame: one minute after propofol infusion
Non-invasive blood pressure (NIBP)
Using the non-invasive blood pressure machine to collect the systolic blood pressure, diastolic blood pressure, and mean arterial pressure
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Heart rate (HR)
Using the electrocardiogram monitor to collect the real-time heart rate
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Oxygen saturation (SpO2)
Using the pulse oximeter to collect the real-time oxygen saturation
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Peak pressure (P peak) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Time frame: 0 minute after LMA placement
Mean pressure (P mean) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Time frame: 0 minute after LMA placement
Ease of jaw opening
A factor for evaluating the condition of LMA insertion
Time frame: Procedure (At the same time of LMA placement)
Ease of LMA insertion
A factor for evaluating the condition of LMA insertion
Time frame: Procedure (At the same time of LMA placement)
Coughing or gagging
Symptoms which suggest non-optimal condition of LMA insertion
Time frame: Within 1 minute after LMA placement
Hiccups
Symptoms which suggest non-optimal condition of LMA insertion
Time frame: Within 1 minute after LMA placement
Head or body movement
Symptoms which suggest non-optimal condition of LMA insertion
Time frame: Within 1 minute after LMA placement
Laryngospasm
Laryngospasm is defined as airway obstruction with assumption that LMA is correctly placed, which is also a factor for evaluating the condition of LMA insertion
Time frame: Within 1 minute after LMA placement
Attempts for LMA insertion
The number of attempts for LMA insertion
Time frame: Procedure (At the same time of LMA placement)
Complications
Including sore throat, dysphagia, dysphonia
Time frame: One hour after LMA removal
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chang Gung Memorial Hospital