Skip to main content
OpenTrials
Completed

NCT Number: NCT05310110

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, General Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkup Chang Gung Memorial Hospital

Taoyuan City, 33305, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10% lidocaine spray

Drug

10% lidocaine spray 3 puff for the throat before induction

Placebo of lidocaine spray

Drug

Normal saline spray 3 puff for the throat before induction

Cisatracurium

Drug

Intravenous cisatracurium 0.12 mg/kg during induction

Placebo of cisatracurium

Drug

Intravenous normal saline during induction

Propofol

Drug

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.

Primary outcomes

  1. Propofol requirement

    Time frame: 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 outcomes

  1. Non-invasive blood pressure (NIBP)

    Time frame: 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

  2. Heart rate (HR)

    Time frame: 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

  3. Oxygen saturation (SpO2)

    Time frame: 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

  4. Peak pressure (P peak) of the airway

    Time frame: 0 minute after LMA placement

    One of the monitoring parameter demonstrated on the mechanical ventilator

  5. Mean pressure (P mean) of the airway

    Time frame: 0 minute after LMA placement

    One of the monitoring parameter demonstrated on the mechanical ventilator

  6. Ease of jaw opening

    Time frame: Procedure (At the same time of LMA placement)

    A factor for evaluating the condition of LMA insertion

  7. Ease of LMA insertion

    Time frame: Procedure (At the same time of LMA placement)

    A factor for evaluating the condition of LMA insertion

  8. Coughing or gagging

    Time frame: Within 1 minute after LMA placement

    Symptoms which suggest non-optimal condition of LMA insertion

  9. Hiccups

    Time frame: Within 1 minute after LMA placement

    Symptoms which suggest non-optimal condition of LMA insertion

  10. Head or body movement

    Time frame: Within 1 minute after LMA placement

    Symptoms which suggest non-optimal condition of LMA insertion

  11. Laryngospasm

    Time frame: 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

  12. Attempts for LMA insertion

    Time frame: Procedure (At the same time of LMA placement)

    The number of attempts for LMA insertion

  13. Complications

    Time frame: One hour after LMA removal

    Including sore throat, dysphagia, dysphonia

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Acronym: LMA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.