Anesthesia, GeneralLMANCT05310110
Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway Insertion Decreasing Propofol in Elderly
A study testing 10% lidocaine spray, Cisatracurium and Propofol in people with Anesthesia, General, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- 10% lidocaine spray, Cisatracurium and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2022to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Age: over 65 years
- Elective orthopedic surgery undergo general anesthesia in supine position
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- 10% lidocaine spray, Placebo of lidocaine spray, Cisatracurium, Placebo of cisatracurium, Propofol
- Keywords
- Muscle relaxants, Laryngeal local anesthetics, Laryngeal mask airway, Laryngeal Masks, LMA, Propofol, Elderly, Aged
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% lidocaine sprayDrug
10% lidocaine spray 3 puff for the throat before induction
Placebo of lidocaine sprayDrug
Normal saline spray 3 puff for the throat before induction
CisatracuriumDrug
Intravenous cisatracurium 0.12 mg/kg during induction
Placebo of cisatracuriumDrug
Intravenous normal saline during induction
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo of lidocaine spray; Drug: Placebo of cisatracurium; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one minute after propofol infusion
Secondary outcomes (13)
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
Measured: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Heart rate (HR)
Using the electrocardiogram monitor to collect the real-time heart rate
Measured: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Oxygen saturation (SpO2)
Using the pulse oximeter to collect the real-time oxygen saturation
Measured: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Peak pressure (P peak) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Measured: 0 minute after LMA placement
Mean pressure (P mean) of the airway
One of the monitoring parameter demonstrated on the mechanical ventilator
Measured: 0 minute after LMA placement
Ease of jaw opening
A factor for evaluating the condition of LMA insertion
Measured: Procedure (At the same time of LMA placement)
Ease of LMA insertion
A factor for evaluating the condition of LMA insertion
Measured: Procedure (At the same time of LMA placement)
Coughing or gagging
Symptoms which suggest non-optimal condition of LMA insertion
Measured: Within 1 minute after LMA placement
Hiccups
Symptoms which suggest non-optimal condition of LMA insertion
Measured: Within 1 minute after LMA placement
Head or body movement
Symptoms which suggest non-optimal condition of LMA insertion
Measured: Within 1 minute after LMA placement
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
Measured: Within 1 minute after LMA placement
Attempts for LMA insertion
The number of attempts for LMA insertion
Measured: Procedure (At the same time of LMA placement)
Complications
Including sore throat, dysphagia, dysphonia
Measured: One hour after LMA removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start12 Apr 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ting, Hung, Chang Gung Memorial Hospital
- Investigators
- Chung Yung-Tai, MD, Study chair, Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical CenterHung Yu-Ting, MD, Principal investigator, Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310110
- Sponsor's protocol ID
- 202200004A3
- Acronym
- LMA
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05310110
- Acronym / sponsor ID
- LMA / 202200004A3
- Conditions
- Anesthesia, General
- Keywords
- Muscle relaxants, Laryngeal local anesthetics, Laryngeal mask airway, Laryngeal Masks, LMA, Propofol, Elderly, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10% lidocaine spray and cisatracurium group | Experimental | Drug: 10% lidocaine spray, Drug: Cisatracurium, Drug: PropofolThe 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. |
| 10% lidocaine spray and placebo of cisatracurium group | Experimental | Drug: 10% lidocaine spray, Drug: Placebo of cisatracurium, Drug: PropofolThe 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. |
| Placebo of lidocaine spray and cisatracurium group | Experimental | Drug: Placebo of lidocaine spray, Drug: Cisatracurium, Drug: PropofolThe 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. |
| Placebo group | Placebo comparator | Drug: Placebo of lidocaine spray, Drug: Placebo of cisatracurium, Drug: PropofolThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Age: over 65 years
- Elective orthopedic surgery undergo general anesthesia in supine position
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% lidocaine spray10% lidocaine spray 3 puff for the throat before induction | Drug | 10% lidocaine spray and cisatracurium group, 10% lidocaine spray and placebo of cisatracurium group |
| Placebo of lidocaine sprayNormal saline spray 3 puff for the throat before induction | Drug | Placebo group, Placebo of lidocaine spray and cisatracurium group |
| CisatracuriumIntravenous cisatracurium 0.12 mg/kg during induction | Drug | 10% lidocaine spray and cisatracurium group, Placebo of lidocaine spray and cisatracurium group |
| Placebo of cisatracuriumIntravenous normal saline during induction | Drug | 10% lidocaine spray and placebo of cisatracurium group, Placebo group |
| PropofolThe 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. | Drug | 10% lidocaine spray and cisatracurium group, 10% lidocaine spray and placebo of cisatracurium group, Placebo group, Placebo of lidocaine spray and cisatracurium group |
Primary outcome
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.
13 secondary outcomes
Non-invasive blood pressure (NIBP)
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Heart rate (HR)
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Oxygen saturation (SpO2)
Time frame: 0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement
Peak pressure (P peak) of the airway
Time frame: 0 minute after LMA placement
Mean pressure (P mean) of the airway
Time frame: 0 minute after LMA placement
Ease of jaw opening
Time frame: Procedure (At the same time of LMA placement)
Ease of LMA insertion
Time frame: Procedure (At the same time of LMA placement)
Coughing or gagging
Time frame: Within 1 minute after LMA placement
Hiccups
Time frame: Within 1 minute after LMA placement
Head or body movement
Time frame: Within 1 minute after LMA placement
Laryngospasm
Time frame: Within 1 minute after LMA placement
Attempts for LMA insertion
Time frame: Procedure (At the same time of LMA placement)
Complications
Time frame: One hour after LMA removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Yung-Tai, MD study chair
Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
Hung Yu-Ting, MD principal investigator
Department of Anesthesiology, Chang Gung Memorial Hospital, Linkou Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% lidocaine spray, Cisatracurium and Propofol in people with Anesthesia, General, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol requirement (time frame: one minute after propofol infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.