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

NCT ID: NCT05310110

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2023-08-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

10% lidocaine spray

Intervention Type: DRUG

10% lidocaine spray 3 puff for the throat before induction

Cisatracurium

Intervention Type: DRUG

Intravenous cisatracurium 0.12 mg/kg during induction

Propofol

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

10% lidocaine spray

Intervention Type: DRUG

10% lidocaine spray 3 puff for the throat before induction

Placebo of cisatracurium

Intervention Type: DRUG

Intravenous normal saline during induction

Propofol

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Placebo of lidocaine spray

Intervention Type: DRUG

Normal saline spray 3 puff for the throat before induction

Cisatracurium

Intervention Type: DRUG

Intravenous cisatracurium 0.12 mg/kg during induction

Propofol

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo of lidocaine spray

Intervention Type: DRUG

Normal saline spray 3 puff for the throat before induction

Placebo of cisatracurium

Intervention Type: DRUG

Intravenous normal saline during induction

Propofol

Intervention Type: 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.

Interventions

10% lidocaine spray

10% lidocaine spray 3 puff for the throat before induction

Intervention Type: DRUG

Placebo of lidocaine spray

Normal saline spray 3 puff for the throat before induction

Intervention Type: DRUG

Cisatracurium

Intravenous cisatracurium 0.12 mg/kg during induction

Intervention Type: DRUG

Placebo of cisatracurium

Intravenous normal saline during induction

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Ting, Hung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chung Yung-Tai, MD

Role: STUDY_CHAIR

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

Hung Yu-Ting, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Linkup Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

202200004A3

Identifier Type: -

Identifier Source: org_study_id