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

Primary Purpose

Anesthesia, General

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
10% lidocaine spray
Placebo of lidocaine spray
Cisatracurium
Placebo of cisatracurium
Propofol
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia, General focused on measuring Muscle relaxants, Laryngeal local anesthetics, Laryngeal mask airway, Laryngeal Masks, LMA, Propofol, Elderly, Aged

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Linkup Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

10% lidocaine spray and cisatracurium group

10% lidocaine spray and placebo of cisatracurium group

Placebo of lidocaine spray and cisatracurium group

Placebo group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Heart rate (HR)
Using the electrocardiogram monitor to collect the real-time heart rate
Oxygen saturation (SpO2)
Using the pulse oximeter to collect the real-time oxygen saturation
Peak pressure (P peak) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Mean pressure (P mean) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Ease of jaw opening
A factor for evaluating the condition of LMA insertion
Ease of LMA insertion
A factor for evaluating the condition of LMA insertion
Coughing or gagging
Symptoms which suggest non-optimal condition of LMA insertion
Hiccups
Symptoms which suggest non-optimal condition of LMA insertion
Head or body movement
Symptoms which suggest non-optimal condition of LMA insertion
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
Attempts for LMA insertion
The number of attempts for LMA insertion
Complications
Including sore throat, dysphagia, dysphonia

Full Information

First Posted
March 16, 2022
Last Updated
May 19, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05310110
Brief Title
Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway Insertion Decreasing Propofol in Elderly
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
March 4, 2023 (Anticipated)
Study Completion Date
March 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General
Keywords
Muscle relaxants, Laryngeal local anesthetics, Laryngeal mask airway, Laryngeal Masks, LMA, Propofol, Elderly, Aged

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10% lidocaine spray and cisatracurium group
Arm Type
Experimental
Arm Description
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.
Arm Title
10% lidocaine spray and placebo of cisatracurium group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo of lidocaine spray and cisatracurium group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
10% lidocaine spray
Intervention Description
10% lidocaine spray 3 puff for the throat before induction
Intervention Type
Drug
Intervention Name(s)
Placebo of lidocaine spray
Intervention Description
Normal saline spray 3 puff for the throat before induction
Intervention Type
Drug
Intervention Name(s)
Cisatracurium
Intervention Description
Intravenous cisatracurium 0.12 mg/kg during induction
Intervention Type
Drug
Intervention Name(s)
Placebo of cisatracurium
Intervention Description
Intravenous normal saline during induction
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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 Outcome Measure Information:
Title
Propofol requirement
Description
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.
Time Frame
one minute after propofol infusion
Secondary Outcome Measure Information:
Title
Non-invasive blood pressure (NIBP)
Description
Using the non-invasive blood pressure machine to collect the systolic blood pressure, diastolic blood pressure, and mean arterial pressure
Time Frame
0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Title
Heart rate (HR)
Description
Using the electrocardiogram monitor to collect the real-time heart rate
Time Frame
0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Title
Oxygen saturation (SpO2)
Description
Using the pulse oximeter to collect the real-time oxygen saturation
Time Frame
0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Title
Peak pressure (P peak) of the airway
Description
One of the monitoring parameter demonstrated on the mechanical ventilator
Time Frame
0 minute after LMA placement
Title
Mean pressure (P mean) of the airway
Description
One of the monitoring parameter demonstrated on the mechanical ventilator
Time Frame
0 minute after LMA placement
Title
Ease of jaw opening
Description
A factor for evaluating the condition of LMA insertion
Time Frame
Procedure (At the same time of LMA placement)
Title
Ease of LMA insertion
Description
A factor for evaluating the condition of LMA insertion
Time Frame
Procedure (At the same time of LMA placement)
Title
Coughing or gagging
Description
Symptoms which suggest non-optimal condition of LMA insertion
Time Frame
Within 1 minute after LMA placement
Title
Hiccups
Description
Symptoms which suggest non-optimal condition of LMA insertion
Time Frame
Within 1 minute after LMA placement
Title
Head or body movement
Description
Symptoms which suggest non-optimal condition of LMA insertion
Time Frame
Within 1 minute after LMA placement
Title
Laryngospasm
Description
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
Time Frame
Within 1 minute after LMA placement
Title
Attempts for LMA insertion
Description
The number of attempts for LMA insertion
Time Frame
Procedure (At the same time of LMA placement)
Title
Complications
Description
Including sore throat, dysphagia, dysphonia
Time Frame
One hour after LMA removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung Yu-Ting, MD
Phone
+886978989137
Email
joycehong05@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Yung-Tai, MD
Phone
+886975365738
Email
oj8600chung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung Yung-Tai, MD
Organizational Affiliation
Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hung Yu-Ting, MD
Organizational Affiliation
Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkup Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung Yu-Ting, MD
Phone
+886978989137
Email
joycehong05.tw@gmail.com
First Name & Middle Initial & Last Name & Degree
Chung Yung-Tai, MD
Phone
+886975365738
Email
oj8600chung@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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