- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139591
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
196
Phase
- 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
-
-
DKI Jakarta
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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
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 |
Intervention / Treatment |
---|---|
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
|
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
|
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
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
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
- Seet E, Yousaf F, Gupta S, Subramanyam R, Wong DT, Chung F. Use of manometry for laryngeal mask airway reduces postoperative pharyngolaryngeal adverse events: a prospective, randomized trial. Anesthesiology. 2010 Mar;112(3):652-7. doi: 10.1097/ALN.0b013e3181cf4346.
- An J, Shin SK, Kim KJ. Laryngeal mask airway insertion in adults: comparison between fully deflated and partially inflated technique. Yonsei Med J. 2013 May 1;54(3):747-51. doi: 10.3349/ymj.2013.54.3.747.
- Uzture N, Menda F, Bilgen S, Keskin O, Temur S, Koner O. The Effect of Flurbiprofen on Postoperative Sore Throat and Hoarseness After LMA-ProSeal Insertion: A Randomised, Clinical Trial. Turk J Anaesthesiol Reanim. 2014 Jun;42(3):123-7. doi: 10.5152/TJAR.2014.35693. Epub 2014 Mar 11.
- Sun L, Guo R, Sun L. Dexamethasone for preventing postoperative sore throat: a meta-analysis of randomized controlled trials. Ir J Med Sci. 2014 Dec;183(4):593-600. doi: 10.1007/s11845-013-1057-0. Epub 2013 Dec 20.
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)
November 1, 2016
Primary Completion (Actual)
January 31, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Aspiration
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Dexamethasone
- Lidocaine
Other Study ID Numbers
- IndonesiaUAnes014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Study Data/Documents
-
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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