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

NCT05310110 | Completed

• 1 other identifier: 202200004A3
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Keywords

Muscle relaxants; Laryngeal local anesthetics; Laryngeal mask airway, Laryngeal Masks, LMA; Propofol; Elderly, Aged

Outcome Measures

Primary Outcomes (1)

• 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.

  one minute after propofol infusion

Secondary Outcomes (13)

• 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

• Oxygen saturation (SpO2)

  0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement

• Peak pressure (P peak) of the airway

  0 minute after LMA placement

• Mean pressure (P mean) of the airway

  0 minute after LMA placement

Study Arms (4)

10% lidocaine spray and cisatracurium group

EXPERIMENTAL

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; Drug: Cisatracurium; Drug: Propofol

10% lidocaine spray and placebo of cisatracurium group

EXPERIMENTAL

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; Drug: Placebo of cisatracurium; Drug: Propofol

Placebo of lidocaine spray and cisatracurium group

EXPERIMENTAL

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; Drug: Cisatracurium; Drug: Propofol

Placebo group

PLACEBO COMPARATOR

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; Drug: Placebo of cisatracurium; Drug: Propofol

Interventions

10% lidocaine spray DRUG

10% lidocaine spray 3 puff for the throat before induction

10% lidocaine spray and cisatracurium group; 10% lidocaine spray and placebo of cisatracurium group

Placebo of lidocaine spray DRUG

Normal saline spray 3 puff for the throat before induction

Placebo group; Placebo of lidocaine spray and cisatracurium group

Cisatracurium DRUG

Intravenous cisatracurium 0.12 mg/kg during induction

10% lidocaine spray and cisatracurium group; Placebo of lidocaine spray and cisatracurium group

Placebo of cisatracurium DRUG

Intravenous normal saline during induction

10% lidocaine spray and placebo of cisatracurium group; Placebo group

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.

10% lidocaine spray and cisatracurium group; 10% lidocaine spray and placebo of cisatracurium group; Placebo group; Placebo of lidocaine spray and cisatracurium group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III
• Age: over 65 years
• Elective orthopedic surgery undergo general anesthesia in supine position

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkup Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

cisatracurium; Propofol

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chung Yung-Tai, MD

  Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center

  STUDY CHAIR

• Hung Yu-Ting, MD

  Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: April 12, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)