Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107556340028 Date of Approval: 05/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ultrasound-guided superior laryngeal nerve block in improving the clinical outcome of pediatric bronchoscopy
Official scientific title A randomized controlled trial of the efficacy of ultrasound-guided superior laryngeal nerve block in improving the clinical outcome of pediatric bronchoscopy procedures
Brief summary describing the background and objectives of the trial Anesthesia for rigid bronchoscopy is a challenging procedure for the anesthesiologist who must share the airway with the bronchoscopist and maintain adequate depth of anesthesia, Major complications may occur during rigid bronchoscopy include severe laryngeal edema or bronchospasm requiring tracheotomy or reintubation, pneumothorax, pneumomediastinum, cardiac arrest, tracheal or bronchial laceration, and hypoxic brain damage. Superior laryngeal nerve (SLN) block has been used effectively in awake endotracheal tube intubation, endoscopic laryngeal surgery, and laryngeal surgery on patients with a neuromuscular disorder. This study aims to evaluate the efficacy of superior laryngeal nerve block in reducing the incidence of postoperative cough, stridor, and wheezes and preservation of hemodynamic in pediatric patients undergoing rigid bronchoscopy. It is hypothesized that SLNB block will improve postoperative cough after rigid bronchoscopy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/06/2021
Actual trial start date 06/07/2021
Anticipated date of last follow up 29/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group superior laryngeal nerve block for bronchoscopy 10 minutes A high-frequency linear ultrasound transducer will be placed probe transversely over the hyoid bone. After identification of the body and greater cornua of HB, Thyroid Cartilage (TC), and its superior cornua, the needle will be inserted laterally to medially in-plane to the probe. 1.5 ml 0.9% normal saline will be deposited below the greater cornua of the HB and above the superior cornua of TC to block the SLN. 30
Control Group placebo injection 10 minutes 1.5 ml 0.9% normal saline will be below the greater cornua of the HB will be performed under strict aseptic precautions. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• American Society of Anesthesiologists (ASA) status: 1 or 2. •undergoing rigid bronchoscopy either as a routine or emergency procedure •Any congenital skeletal deformities •Cardiovascular disorders. •Bleeding or coagulation diathesis. •History of known sensitivity to the used anesthetics. •Parental refusal of consent. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 8 Year(s) Both
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 07/04/2021 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of postoperative cough(the visual analog scale)by parents (VAS). Up to 1 hour after the bronchoscopy procedure
Secondary Outcome the incidence of stridor Up to 1 hour after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mahmoud Mohammed Alseoudy 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Alseoudy 2 El-Gomhouria Street 35516 Mansoura 35516 Egypt
Hossam Saber 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Alseoudy drs3ody.mansora@mans.edu.eg +201006224551 Abdsalalm Aref street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries hossam Saber hosamisaber@gmail.com +201096024142 Gehan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 ElGomhouria Street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide summary results or a link to summary results within 12 months of the study completion date. Informed Consent Form,Study Protocol within 12 months of the study completion date. We will provide individual participant data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Link To Protocol No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information