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The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

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ClinicalTrials.gov Identifier: NCT01445847
Recruitment Status : Terminated (Patient Safety Concerns)
First Posted : October 4, 2011
Results First Posted : July 12, 2012
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Khalid Ibrahim Aljonaieh, King Saud University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Laryngospasm
Interventions: Drug: Lidocaine
Other: Placebo

  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
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   50   50 
COMPLETED   36   36 
NOT COMPLETED   14   14 
Protocol Violation                13                14 
Missed Data                1                0 

  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
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 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      36 100.0%      36 100.0%      72 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 35.61  (8.73)   39.39  (10.84)   38.01  (10.51868595) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      31  86.1%      26  72.2%      57  79.2% 
Male      5  13.9%      10  27.8%      15  20.8% 
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

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

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
First Submitted: September 29, 2011
First Posted: October 4, 2011
Results First Submitted: June 11, 2012
Results First Posted: July 12, 2012
Last Update Posted: May 22, 2017