Study Stopped
Patient Safety Concerns
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
July 12, 2012
CompletedMay 22, 2017
April 1, 2017
3 months
September 29, 2011
June 11, 2012
April 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
within first 15 minutes post-dose
Study Arms (2)
Lidocaine
ACTIVE COMPARATORLidocaine 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 COMPARATORNormal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
Interventions
1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesia score are I or II
- Undergo for laparoscopic cholecystectomy
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Medicine - King Saud University Medical City
Riyadh, Riyadh Region, 11472, Saudi Arabia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Khalid Al-Faleh, Chairman, Institutional Review Board
- Organization
- King Saud University Medical City - College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Khalid I Aljonaieh, Lecturer
King Saud University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 4, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 22, 2017
Results First Posted
July 12, 2012
Record last verified: 2017-04