Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone in Reducing Pain After Laryngeal Mask Insertion

August 15, 2017 updated by: Susilo Chandra, Indonesia University

Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone to Reduce Pain After Laryngeal Mask Insertion

This study aimed to compare the efficacy between lidocaine inhalation vs intravenous dexamethasone to reduce pain after laryngeal mask insertion

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine inhalation and Intravenous dexamethasone group). Intravenous (IV) cannula (18 or 20 G) , non-invasive blood pressure monitor, and pulse-oxymetry had been set on the subjects 10 minutes before anesthesia began. Vital signs were recorded. Lidocaine group received 1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection. Dexamethasone group received normal saline inhalation and 10 mg of intravenous dexamethasone. Subjects, authors, or inhalation giver were not aware of the content of any drug given. Coinduction was done using 0.05mg/kg BW of midazolam and 2mcg/kg BW of fentanyl 5 minutes before the laryngeal mask airway (LMA) insertion. Induction was done using 2 mg/kg BW of 1% propofol and 0.5 mg/kg BW of atracurium 3 minutes before LMA insertion. Subjects were then given oxygenation using face mask without oropharyngeal airway. LMA was lubricated with normal saline. After 3 minutes of oxygenation, LMA was inserted using standard method. The LMA cuff was inflated with cuff pressure gauge of approximately 40 mmHg. After the position of LMA was confirmed to be correct, fixation was done using a tape. Maintenance of anesthesia was done using 50% oxygen in compressed air, 1% isoflurane, and atracurium. Thirty minutes before the surgery ended, 1 gram of paracetamol was given in 15 minutes as post-surgery analgetic. After the surgery was ended, subjects were given 0.04 mg/kg BW of neostigmine and 0.02 mg/kg BW of atropine. Mucus suction was performed on oropharynx and oral cavity gently, by using suction catheter 12F when subjects were still under anesthesia. After spontaneous breaths occured, LMA cuff was deflated and LMA was removed. Ventilation was continued using face mask without oropharyngeal airway. At the recovery room, pain on throat was assessed using Numerical Rating Scale. Assessment was done 2 hours after surgery in the recovery room after subjects were fully alert with Aldrette score of 10. Throat pain was assessed during rest or swallowing. In addition, subjects were asked whether or not they experienced difficulty in swallowing or hoarseness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Central Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 20-59 years old, with American Society of Anesthesiologists (ASA) physical status of I-II who were planned to undergo any elective surgery at operating room in general anesthesia and needed LMA insertion
  • Mallampati class I or II
  • subjects had been explained about the study, and agreed to enroll and have signed the informed consent form
  • Subjects without history of throat pain

Exclusion Criteria:

  • Subjects with cardiovascular disease, history of analgetic and steroid before surgery, surgical site of neck, oral cavity, pharynx, and larynx
  • Subjects with upper respiratory tract infection
  • Subjects with history of drug allergy used in the trial and possibility of difficult airway
  • Pregnant, obese, active smoking, uncontrolled diabetic and hypertension subjects
  • Subjects with history of peptic ulcer disease.

Dropout Criteria:

  • Subjects whose LMA insertion attempts more than once
  • Subjects with surgery duration > 150 minutes
  • Subjects who needed mechanical ventilation after surgery, subjects who vomitted
  • Subjects whose LMA converted to endotracheal tube during surgery
  • Subjects who received additional opioid during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: lidocaine inhalation
Lidocaine inhalation group: 1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection
Drug: lidocaine inhalation; intravenous dexamethasone
1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection; Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone.
Active Comparator: intravenous dexamethasone
Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone
Drug: lidocaine inhalation; intravenous dexamethasone
1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection; Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical rating scale
Time Frame: Day 1
Numerical rating scale for throat pain
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IndonesiaUAnes014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Textbook
    Information comments: Problems. In: Brimacombe JR. Laryngeal Mask Anesthesia principles and practice. London: Saunders Ltd, 2004;551-71.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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