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Clinical Trials/NCT05310110
NCT05310110
Completed
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country96 target enrollmentApril 12, 2022

Overview

Phase
Not Applicable
Intervention
10% lidocaine spray
Conditions
Anesthesia, General
Sponsor
Chang Gung Memorial Hospital
Enrollment
96
Locations
1
Primary Endpoint
Propofol requirement
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2022
End Date
August 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yu-Ting, Hung

Principal Investigator

Chang Gung Memorial Hospital

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

Arms & Interventions

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.

Intervention: 10% lidocaine spray

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.

Intervention: Cisatracurium

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.

Intervention: Propofol

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.

Intervention: 10% lidocaine spray

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.

Intervention: Placebo of cisatracurium

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.

Intervention: Propofol

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.

Intervention: Placebo of lidocaine spray

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.

Intervention: Cisatracurium

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.

Intervention: Propofol

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.

Intervention: Placebo of lidocaine spray

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.

Intervention: Placebo of cisatracurium

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.

Intervention: Propofol

Outcomes

Primary Outcomes

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

  • Coughing or gagging(Within 1 minute after LMA placement)
  • Oxygen saturation (SpO2)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
  • Ease of LMA insertion(Procedure (At the same time of LMA placement))
  • Non-invasive blood pressure (NIBP)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
  • Heart rate (HR)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
  • Head or body movement(Within 1 minute after LMA placement)
  • Peak pressure (P peak) of the airway(0 minute after LMA placement)
  • Hiccups(Within 1 minute after LMA placement)
  • Mean pressure (P mean) of the airway(0 minute after LMA placement)
  • Ease of jaw opening(Procedure (At the same time of LMA placement))
  • Attempts for LMA insertion(Procedure (At the same time of LMA placement))
  • Complications(One hour after LMA removal)
  • Laryngospasm(Within 1 minute after LMA placement)

Study Sites (1)

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