Laryngospasm
Conditions
Keywords
Laryngospasm, Lidocaine
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.
Interventions
DRUGLidocaine
1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
OTHERPlacebo
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
Sponsors
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Laryngospasm Postoperatively | within first 15 minutes post-dose | There were 4 scores of laryngospasm: 0 = No Laryngospasm 1. = Stridor or partial laryngospasm 2. = Complete Laryngospasm 3. = Cyanosis |
Countries
Saudi Arabia
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued | 36 |
| Placebo Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed Data | 1 | 0 |
| Overall Study | Protocol Violation | 13 | 14 |
Baseline characteristics
| Characteristic | Lidocaine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Continuous | 35.61 years STANDARD_DEVIATION 8.73 | 39.39 years STANDARD_DEVIATION 10.84 | 38.01 years STANDARD_DEVIATION 10.51868595 |
| Region of Enrollment Saudi Arabia | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 31 Participants | 26 Participants | 57 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 7 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Number of Patients With Laryngospasm Postoperatively
There were 4 scores of laryngospasm: 0 = No Laryngospasm 1. = Stridor or partial laryngospasm 2. = Complete Laryngospasm 3. = Cyanosis
Time frame: within first 15 minutes post-dose
Population: Trial was terminated by data monitoring committee due to safety concerns
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Number of Patients With Laryngospasm Postoperatively | 0 participants |
| Placebo | Number of Patients With Laryngospasm Postoperatively | 7 participants |
Comparison: We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.p-value: <0.0595% CI: [1.7, 9.1]Comparison of proportions