Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway Insertion Decreasing Propofol in Elderly
- Conditions
- Anesthesia, General
- Interventions
- Registration Number
- NCT05310110
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- American Society of Anesthesiologists (ASA) physical status I-III
- Age: over 65 years
- Elective orthopedic surgery undergo general anesthesia in supine position
- Anticipated difficult airway (Mallampati score 3-4), limited mouth opening, intra-oral and pharyngeal pathology
- Risk of pulmonary aspiration of gastric contents (full stomach)
- Obesity (Body mass index > 35)
- Significant lung abnormalities (low lung compliance, high airway resistance, impaired oxygenation)
- Loosening teeth
- Allergic to Cisatracurium or Lidocaine
- Failure in successful LMA insertion after second attempts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 10% lidocaine spray and placebo of cisatracurium group 10% lidocaine spray 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. 10% lidocaine spray and placebo of cisatracurium group Placebo of cisatracurium 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. Placebo of lidocaine spray and cisatracurium group Placebo of lidocaine spray 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. Placebo group Placebo of lidocaine spray 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. 10% lidocaine spray and cisatracurium group 10% lidocaine spray 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. Placebo group Placebo of cisatracurium 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. 10% lidocaine spray and cisatracurium group Propofol 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. 10% lidocaine spray and cisatracurium group Cisatracurium 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. Placebo of lidocaine spray and cisatracurium group Cisatracurium 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. 10% lidocaine spray and placebo of cisatracurium group 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. Placebo of lidocaine spray and cisatracurium group 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. Placebo group 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.
- Primary Outcome Measures
Name Time Method Propofol requirement one minute after propofol infusion 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.
- Secondary Outcome Measures
Name Time Method Coughing or gagging Within 1 minute after LMA placement Symptoms which suggest non-optimal condition of LMA insertion
Oxygen saturation (SpO2) 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement Using the pulse oximeter to collect the real-time oxygen saturation
Ease of LMA insertion Procedure (At the same time of LMA placement) A factor for evaluating the condition of LMA insertion
Non-invasive blood pressure (NIBP) 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement Using the non-invasive blood pressure machine to collect the systolic blood pressure, diastolic blood pressure, and mean arterial pressure
Heart rate (HR) 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement Using the electrocardiogram monitor to collect the real-time heart rate
Head or body movement Within 1 minute after LMA placement Symptoms which suggest non-optimal condition of LMA insertion
Peak pressure (P peak) of the airway 0 minute after LMA placement One of the monitoring parameter demonstrated on the mechanical ventilator
Hiccups Within 1 minute after LMA placement Symptoms which suggest non-optimal condition of LMA insertion
Mean pressure (P mean) of the airway 0 minute after LMA placement One of the monitoring parameter demonstrated on the mechanical ventilator
Ease of jaw opening Procedure (At the same time of LMA placement) A factor for evaluating the condition of LMA insertion
Attempts for LMA insertion Procedure (At the same time of LMA placement) The number of attempts for LMA insertion
Complications One hour after LMA removal Including sore throat, dysphagia, dysphonia
Laryngospasm Within 1 minute after LMA placement 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
Trial Locations
- Locations (1)
Linkup Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan