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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01445847
Date of registration: 29/09/2011
Prospective Registration: Yes
Primary sponsor: King Saud University
Public title: The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Scientific title: Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
Date of first enrolment: January 2012
Target sample size: 134
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01445847
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Saudi Arabia
Contacts
Name:     Khalid I Aljonaieh, Lecturer
Address: 
Telephone:
Email:
Affiliation:  King Saud University
Key inclusion & exclusion criteria

Inclusion Criteria:

- American Society of Anesthesia score are I or II

- Undergo for laparoscopic cholecystectomy

Exclusion Criteria:

- 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

- ß -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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Laryngospasm
Intervention(s)
Drug: Lidocaine
Other: Placebo
Primary Outcome(s)
Number of Patients With Laryngospasm Postoperatively [Time Frame: within first 15 minutes post-dose]
Secondary Outcome(s)
Secondary ID(s)
E-11-491
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 12/07/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01445847
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