Clinical trial NCT05310110: Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway Insertion Decreasing Propofol in Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: Muscle relaxants
Laryngeal local anesthetics
Laryngeal mask airway, Laryngeal Masks, LMA
Propofol
Elderly, Aged
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Propofol requirement
timeFrame: one minute after propofol infusion
Secondary outcomes:
measure: Non-invasive blood pressure (NIBP)
timeFrame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
measure: Heart rate (HR)
timeFrame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
measure: Oxygen saturation (SpO2)
timeFrame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
measure: Peak pressure (P peak) of the airway
timeFrame: 0 minute after LMA placement
measure: Mean pressure (P mean) of the airway
timeFrame: 0 minute after LMA placement
measure: Ease of jaw opening
timeFrame: Procedure (At the same time of LMA placement)
measure: Ease of LMA insertion
timeFrame: Procedure (At the same time of LMA placement)
measure: Coughing or gagging
timeFrame: Within 1 minute after LMA placement
measure: Hiccups
timeFrame: Within 1 minute after LMA placement
measure: Head or body movement
timeFrame: Within 1 minute after LMA placement
measure: Laryngospasm
timeFrame: Within 1 minute after LMA placement
measure: Attempts for LMA insertion
timeFrame: Procedure (At the same time of LMA placement)
measure: Complications
timeFrame: One hour after LMA removal
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkup Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
name: Chung Yung-Tai, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
name: Hung Yu-Ting, MD
role: PRINCIPAL_INVESTIGATOR
References: