Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201607001643276 Date of Approval: 19/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Propofol for laryngospasm
Official scientific title Low dose propofol versus lidocaine for relief of resistant post-extubation laryngospasm in the obstetric patient
Brief summary describing the background and objectives of the trial Post-extubation laryngospasm is a life-threatening anesthetic emergency that needs prompt treatment. It is a dangerous complication that may lead to hypoxia or negative pressure pulmonary edema. Some studies listed laryngospasm as an anesthetic cause of obstetric mortality. Standard measures described for management of laryngospasm started with removal of the offending stimulus, jaw thrust, and positive airway pressure ventilation with 100% oxygen by bag and mask. When these measures fail, a small dose (0.1 mg/kg) of iv succinylcholine is used. Some studies suggested the use of topical or iv lidocaine. The use of small dose of propofol have been suggested for treatment of resistant laryngospasm in pediatric patients, because of its depressive effect on laryngeal reflexes. Other studies tried a small dose of propofol (0.5 mg/kg) for resistant laryngospasm in obstetric anesthesia. This work aims to compare the effectiveness of a small dose of propofol (0.5 ml/kg) versus lidocaine (1.5 mg/kg) for treatment of resistant post-extubation laryngospasm in obstetric patients, after failure of the standard measures and before the use of muscle relaxants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Laryngospasm,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2014
Actual trial start date 10/01/2014
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 20/12/2015
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants) 78
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised a quasi-randomised controlled trial. Patients developed laryngospasm during the two years initially managed with a standard protocol. Resistant cases were allocated as: In the first year, we gave iv lidocaine and allocated in group I, while in the second year we gave iv propofol and allocated in group II. Cases resistant to drugs in both groups received iv succinylcholine to relieve the spasm a quasi-randomised controlled trial. Patients developed laryngospasm during the two years initially managed with a standard protocol. Resistant cases were allocated as: In the first year, we gave iv lidocaine and allocated in group I, while in the second year we gave iv propofol and allocated in group II. Cases resistant to drugs in both groups received iv succinylcholine to relieve the spasm Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group propofol 0.5 mg/kg Intravenous adminstration 37
Control Group Lidocaine 1.5 mg/kg intravenous adminstration 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All parturients of ASA class I or II, who were scheduled for cesarean section under general anesthesia, suffered from post-extubation laryngospasm. known sensitivity to lidocaine or propofol upper respiratory tract infection history of bronchial asthma or other lung diseases chronic smoking chronic exposure to smokers, dust or fumes. 20 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2013 Kasr Al Ainy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy st. Cairo 11559 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome relief of laryngospasm If the spasm was not relieved and oxygen saturation dropped to 85%,we gave a dose of iv succinylcholine (0.5 mg/kg) to relieve the spasm and restore ventilation
Secondary Outcome incidence of complications (gastric distension, aspiration, NPPE, arrhythmias, or cardiac arrest) During or after relief of laryngospasm.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Al Ainy st. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Anesthesia, Cairo University. Kasr Al AIny st. Cairo 11559 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia, Cairo University. Kasr Al Ainy st. Cairo 11933 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Badawy Kasr Al Ainy st. Cairo 11933 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Mokhtar alyaly4444@gmail.com +201114999890 Kasr Al Ainy st.
City Postal code Country Position/Affiliation
Cairo 11933 Egypt Lecturer of Anesthesia, Cairo university
Role Name Email Phone Street address
Public Enquiries Ali Mokhtar alyaly4444@gmail.com 01114999890 Kasr Al Ainy st. Cairo university Hospitals
City Postal code Country Position/Affiliation
New Maadi 11933 Egypt Lecturer of Anesthesia, Cairo university.
Role Name Email Phone Street address
Scientific Enquiries Cairo University alyaly4444@gmail.com 01114999890 Kasr Al Ainy st.
City Postal code Country Position/Affiliation
Cairo 11933 Egypt Cairo University
REPORTING
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