LaryngospasmNCT01445847
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
A study testing Lidocaine in people with Laryngospasm, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laryngospasm
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesia score are I or II
- Undergo for laparoscopic cholecystectomy
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Medicine - King Saud University Medical City
Riyadh, Riyadh Region, 11472
About this study
Official title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Laryngospasm
- Being tested
- Lidocaine, Placebo
- Keywords
- Laryngospasm, Lidocaine
- Medical subject headings
- Laryngismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
PlaceboOther
Also called Normal Saline
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Laryngospasm Postoperatively
There were 4 scores of laryngospasm:
0 = No Laryngospasm
- = Stridor or partial laryngospasm
- = Complete Laryngospasm
- = Cyanosis
Measured: within first 15 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Patient Safety Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LaryngospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Ibrahim Aljonaieh, King Saud University
- Investigators
- Khalid I Aljonaieh, Lecturer, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445847
- Sponsor's protocol ID
- E-11-491
- Status last verified
- Apr 2017
- First submitted
- 29 Sep 2011
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01445847
- Acronym / sponsor ID
- E-11-491
- Conditions
- Laryngospasm
- Keywords
- Laryngospasm, Lidocaine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient Safety Concerns
- Enrolment
- 134 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 12 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineLidocaine 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 | Other: PlaceboNormal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesia score are I or II
- Undergo for laparoscopic cholecystectomy
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Xylocaine1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued. | Drug | Lidocaine |
| PlaceboAlso: Normal Saline1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued. | Other | Placebo |
Primary outcome
Number of Patients With Laryngospasm Postoperatively
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- King Saud UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid I Aljonaieh, Lecturer principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Laryngospasm, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Laryngospasm Postoperatively (time frame: within first 15 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.