Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone in Reducing Pain After Laryngeal Mask Insertion
Primary Purpose
Adult Patients Undergoing Elective Surgery With General Anesthesia and LMA Insertion
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
lidocaine inhalation; intravenous dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Adult Patients Undergoing Elective Surgery With General Anesthesia and LMA Insertion
Eligibility Criteria
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
Sites / Locations
- Cipto Mangunkusumo Central National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lidocaine inhalation
intravenous dexamethasone
Arm Description
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
Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone
Outcomes
Primary Outcome Measures
Numerical rating scale
Numerical rating scale for throat pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03139591
Brief Title
Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone in Reducing Pain After Laryngeal Mask Insertion
Official Title
Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone to Reduce Pain After Laryngeal Mask Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to compare the efficacy between lidocaine inhalation vs intravenous dexamethasone to reduce pain after laryngeal mask insertion
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients Undergoing Elective Surgery With General Anesthesia and LMA Insertion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lidocaine inhalation
Arm Type
Active Comparator
Arm Description
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
Arm Title
intravenous dexamethasone
Arm Type
Active Comparator
Arm Description
Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone
Intervention Type
Drug
Intervention Name(s)
lidocaine inhalation; intravenous dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical rating scale
Description
Numerical rating scale for throat pain
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto Mangunkusumo Central National Hospital
City
Central Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23549825
Citation
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.
Results Reference
background
PubMed Identifier
20179502
Citation
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.
Results Reference
background
PubMed Identifier
27366405
Citation
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.
Results Reference
background
PubMed Identifier
24357270
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Textbook
Available IPD/Information URL
https://books.google.co.id/books/about/Laryngeal_Mask_Anesthesia.html?id=XBJsAAAAMAAJ&redir_esc=y
Available IPD/Information Comments
Problems. In: Brimacombe JR. Laryngeal Mask Anesthesia principles and practice. London: Saunders Ltd, 2004;551-71.
Learn more about this trial
Comparison Between Lidocaine Inhalation and Intravenous Dexamethasone in Reducing Pain After Laryngeal Mask Insertion
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