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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05310110

Collaborator

(none)

200

Enrollment

Location

Arms

22.7

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General	Drug: 10% lidocaine spray Drug: Placebo of lidocaine spray Drug: Cisatracurium Drug: Placebo of cisatracurium Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

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

Actual Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Mar 4, 2023

Anticipated Study Completion Date :

Mar 4, 2024

Arms and Interventions

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: Placebo of cisatracurium Intravenous normal saline 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: 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: Placebo of lidocaine spray Normal saline 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.
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: Placebo of lidocaine spray Normal saline spray 3 puff for the throat before induction Drug: Placebo of cisatracurium Intravenous normal saline 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.

Outcome Measures

Primary Outcome Measures

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

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
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
Peak pressure (P peak) of the airway [0 minute after LMA placement]
One of the monitoring parameter demonstrated on the mechanical ventilator
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
Ease of LMA insertion [Procedure (At the same time of LMA placement)]
A factor for evaluating the condition of LMA insertion
Coughing or gagging [Within 1 minute after LMA placement]
Symptoms which suggest non-optimal condition of LMA insertion
Hiccups [Within 1 minute after LMA placement]
Symptoms which suggest non-optimal condition of LMA insertion
Head or body movement [Within 1 minute after LMA placement]
Symptoms which suggest non-optimal condition of LMA insertion
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linkup Chang Gung Memorial Hospital	Taoyuan City		Taiwan	33305

Sponsors and Collaborators

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