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Patient Safety Concerns
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Laryngospasm Postoperatively | There were 4 scores of laryngospasm: 0 = No Laryngospasm
| within first 15 minutes post-dose |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Khalid I Aljonaieh, Lecturer | King Saud University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Medicine - King Saud University Medical City | Riyadh | Riyadh Region | 11472 | Saudi Arabia |
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| Label | URL |
|---|---|
| King Saud University | View source |
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Patients were able to refuse to participate before anesthesia induction start. Therefore, patients may excluded from the study due to that reason and we decided to start assignment to groups randomly when anesthesia is induced to the patient.
Study conducted at King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia at Jan 20, 2012. Recruitment was done at Their wards within 24 hours prior to the operation
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued |
| FG001 | Placebo | Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued |
| BG001 | Placebo | Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Laryngospasm Postoperatively | There were 4 scores of laryngospasm: 0 = No Laryngospasm
| Trial was terminated by data monitoring committee due to safety concerns | Posted | Number | participants | within first 15 minutes post-dose |
|
within 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | Laryngospasm | Systematic Assessment |
Early termination of the trial led to small numbers of subjects that received allocated intervention, (i.e., 99 total participants).
Additionally, protocol violation led to reduce the analyze subjects to 36 for each group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Khalid Al-Faleh, Chairman, Institutional Review Board | King Saud University Medical City - College of Medicine | 966556031222 | kfaleh@ksu.edu.sa |
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| ID | Term |
|---|---|
| D007826 | Laryngismus |
| ID | Term |
|---|---|
| D064706 | Vocal Cord Dysfunction |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo | Other | 1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued | 0 | 36 | 7 | 36 |
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| D010038 | Otorhinolaryngologic Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |