Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway Insertion Decreasing Propofol in Elderly (LMA)

The Impact of Using Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway (LMA) Insertion on Hemodynamics and Induction Anesthetics Dosage in Elderly

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Drug: 10% lidocaine spray; Drug: Cisatracurium; Drug: Propofol; Drug: Placebo of cisatracurium; Drug: Placebo of lidocaine spray

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung Yu-Ting, MD; Phone Number: +886978989137; Email: joycehong05@cgmh.org.tw
• Study Contact Backup: Name: Chung Yung-Tai, MD; Phone Number: +886975365738; Email: oj8600chung@gmail.com

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 33305
    • Linkup Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-III
• Age: over 65 years
• Elective orthopedic surgery undergo general anesthesia in supine position

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10% lidocaine spray and cisatracurium group; 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; 10% lidocaine spray 3 puff for the throat before induction; Drug: Cisatracurium; Intravenous cisatracurium 0.12 mg/kg during induction; Drug: Propofol; 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.
Experimental: 10% lidocaine spray and placebo of cisatracurium group; 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; 10% lidocaine spray 3 puff for the throat before induction; Drug: Propofol; 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.; Drug: Placebo of cisatracurium; Intravenous normal saline during induction
Experimental: Placebo of lidocaine spray and cisatracurium group; 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: Cisatracurium; Intravenous cisatracurium 0.12 mg/kg during induction; Drug: Propofol; 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.; Drug: Placebo of lidocaine spray; Normal saline spray 3 puff for the throat before induction
Placebo Comparator: Placebo group; 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: Propofol; 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.; Drug: Placebo of cisatracurium; Intravenous normal saline during induction; Drug: Placebo of lidocaine spray; Normal saline spray 3 puff for the throat before induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one minute after propofol infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	0 minute after LMA placement
Mean pressure (P mean) of the airway	One of the monitoring parameter demonstrated on the mechanical ventilator	0 minute after LMA placement
Ease of jaw opening	A factor for evaluating the condition of LMA insertion	Procedure (At the same time of LMA placement)
Ease of LMA insertion	A factor for evaluating the condition of LMA insertion	Procedure (At the same time of LMA placement)
Coughing or gagging	Symptoms which suggest non-optimal condition of LMA insertion	Within 1 minute after LMA placement
Hiccups	Symptoms which suggest non-optimal condition of LMA insertion	Within 1 minute after LMA placement
Head or body movement	Symptoms which suggest non-optimal condition of LMA insertion	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	Within 1 minute after LMA placement
Attempts for LMA insertion	The number of attempts for LMA insertion	Procedure (At the same time of LMA placement)
Complications	Including sore throat, dysphagia, dysphonia	One hour after LMA removal

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Chung Yung-Tai, MD, Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center; Principal Investigator: Hung Yu-Ting, MD, Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Propofol; Muscle relaxants; Laryngeal local anesthetics; Laryngeal mask airway, Laryngeal Masks, LMA; Elderly, Aged
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Lidocaine; Cisatracurium; Atracurium
• Other Study ID Numbers: 202200004A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No