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The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

This study has been terminated.
(Patient Safety Concerns)
Sponsor:
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University
ClinicalTrials.gov Identifier:
NCT01445847
First received: September 29, 2011
Last updated: January 1, 2015
Last verified: January 2015
Results First Received: June 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Laryngospasm
Interventions: Drug: Lidocaine
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Lidocaine Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
Placebo Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued

Participant Flow:   Overall Study
    Lidocaine   Placebo
STARTED   182   183 
COMPLETED   36   36 
NOT COMPLETED   146   147 
Protocol Violation                13                14 
Terminated by data monitoring committee                133                133 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lidocaine Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
Placebo Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
Total Total of all reporting groups

Baseline Measures
   Lidocaine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   72 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   36   72 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.61  (8.73)   39.39  (10.84)   38.01  (10.51868595) 
Gender 
[Units: Participants]
     
Female   31   26   57 
Male   5   10   15 
Region of Enrollment 
[Units: Participants]
     
Saudi Arabia   36   36   72 


  Outcome Measures

1.  Primary:   Number of Patients With Laryngospasm Postoperatively   [ Time Frame: within first 15 minutes post‐dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Khalid Al-Faleh, Chairman, Institutional Review Board
Organization: King Saud University Medical City - College of Medicine
phone: 966556031222
e-mail: kfaleh@ksu.edu.sa



Responsible Party: Khalid Ibrahim Aljonaieh, King Saud University
ClinicalTrials.gov Identifier: NCT01445847     History of Changes
Other Study ID Numbers: E-11-491
Study First Received: September 29, 2011
Results First Received: June 11, 2012
Last Updated: January 1, 2015
Health Authority: Saudi Arabia: Ministry for Higher Education