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

Anesthesia, General Clinical Trial

— LMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310110
• Other study ID #: 202200004A3
• Status: Completed
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Muscle Hypotonia

Intervention

Drug:
• 10% lidocaine spray
10% lidocaine spray 3 puff for the throat before induction
• Placebo of lidocaine spray
Normal saline spray 3 puff for the throat before induction
• Cisatracurium
Intravenous cisatracurium 0.12 mg/kg during induction
• Placebo of cisatracurium
Intravenous normal saline during induction
• 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.

Locations

Country	Name	City	State
Taiwan	Linkup Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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