Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

This study has been completed.
Sponsor:
Collaborator:
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University
ClinicalTrials.gov Identifier:
NCT01445847
First received: September 29, 2011
Last updated: July 11, 2012
Last verified: July 2012
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);   Primary Purpose: Prevention
Condition: Laryngospasm
Interventions: Drug: Lidocaine
Other: Placebo

  Participant Flow
  Hide Participant Flow

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 (or mg) per kg bolus immediately when inhalational gas (Desflurane) turned off
Placebo Placebo group received 1 ml per kg bolus immediately when inhalational gas (Desflurane) turned off

Participant Flow:   Overall Study
    Lidocaine     Placebo  
STARTED     49     50  
COMPLETED     49     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 (or mg) per kg bolus immediately when inhalational gas (Desflurane) turned off
Placebo Placebo group received 1 ml per kg bolus immediately when inhalational gas (Desflurane) turned off
Total Total of all reporting groups

Baseline Measures
    Lidocaine     Placebo     Total  
Number of Participants  
[units: participants]
  49     50     99  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     49     50     99  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.16  ± 9.54     39.82  ± 11.2     38.01  ± 10.51868595  
Gender  
[units: participants]
     
Female     39     36     75  
Male     10     14     24  
Region of Enrollment  
[units: participants]
     
Saudi Arabia     49     50     99  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Laryngospasm Postoperatively   [ Time Frame: within first 5 minutes post‐dose ]

2.  Secondary:   Number of Patients With Incidence of Cough Postoperatively   [ Time Frame: within first 5 minutes post‐dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Premedicate patient with sedation drugs like Lorazepam and Midazolam led to reduce number of participants during analyze process from 50 to 36 for each group.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Effect of Intravenous Lidocaine on the Incidence of Post-Extubation Laryngospasm
Organization: Khalid Aljonaieh
phone: 966544300777
e-mail: kaljonaieh@ksu.edu.sa


No publications provided


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: July 11, 2012
Health Authority: Saudi Arabia: Ministry for Higher Education