The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Primary Purpose
Laryngospasm
Status
Terminated
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Laryngospasm focused on measuring Laryngospasm, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesia score are I or II
- Undergo for laparoscopic cholecystectomy
Exclusion Criteria:
- Patient's refusal
- History of upper respiratory tract infection (URTI) within 2 weeks
- Persistent type of hyper-reactive airway or asthma
- History of airway surgery
- History of gastro-esophageal reflex disease (GERD)
- Currently receiving sedating or analgesic medication
Currently receiving the following medications:
- Fluvoxamine
- Erythromycin and Itraconazole
- β -blocker or Cimetidine
- History of Lidocaine Allergy
- History of epilepsy disorder
- Pregnant or breastfeeding women
- History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
- History of increased salivation by a disease or medication
- History of difficult intubation
- Two or more attempts of intubation
Sites / Locations
- College of Medicine - King Saud University Medical City
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine
Placebo
Arm Description
Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100
Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
Outcomes
Primary Outcome Measures
Number of Patients With Laryngospasm Postoperatively
There were 4 scores of laryngospasm:
0 = No Laryngospasm
= Stridor or partial laryngospasm
= Complete Laryngospasm
= Cyanosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01445847
Brief Title
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Official Title
Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Patient Safety Concerns
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.
The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.
Detailed Description
During anesthesia practice, one of the common complications of airway management is laryngospasm. The etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. Laryngospasm occurs in both genders and all ages. Incidence of laryngospasm was reported to the Australian incident monitoring study (AIMS) was 5% with of 22% of them without an attributable cause.
Currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. However, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence.
Intravenous (IV) lidocaine interrupts nerve conduction by blocking sodium channels. Recent meta-analysis study showed that IV lidocaine was able to prevent laryngospasm in children. However, in the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.
The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngospasm
Keywords
Laryngospasm, Lidocaine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
Primary Outcome Measure Information:
Title
Number of Patients With Laryngospasm Postoperatively
Description
There were 4 scores of laryngospasm:
0 = No Laryngospasm
= Stridor or partial laryngospasm
= Complete Laryngospasm
= Cyanosis
Time Frame
within first 15 minutes post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesia score are I or II
Undergo for laparoscopic cholecystectomy
Exclusion Criteria:
Patient's refusal
History of upper respiratory tract infection (URTI) within 2 weeks
Persistent type of hyper-reactive airway or asthma
History of airway surgery
History of gastro-esophageal reflex disease (GERD)
Currently receiving sedating or analgesic medication
Currently receiving the following medications:
Fluvoxamine
Erythromycin and Itraconazole
β -blocker or Cimetidine
History of Lidocaine Allergy
History of epilepsy disorder
Pregnant or breastfeeding women
History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
History of increased salivation by a disease or medication
History of difficult intubation
Two or more attempts of intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid I Aljonaieh, Lecturer
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Medicine - King Saud University Medical City
City
Riyadh
ZIP/Postal Code
11472
Country
Saudi Arabia
12. IPD Sharing Statement
Links:
URL
http://ksu.edu.sa
Description
King Saud University
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The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
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