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.: PACTR202405675858601 Date of Approval: 22/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Low ‑dose Atracurium for Laryngeal Mask Airway Insertion in ophthalmic Surgeries
Official scientific title Low ‑dose Atracurium for Laryngeal Mask Airway Insertion in ophthalmic Surgeries
Brief summary describing the background and objectives of the trial Laryngeal mask airway is one of the airway control tools for managing common airway problems under general anesthesia and airway emergency. So that, the LMA has been highly adapted to difficult airway management protocols, as a result it has been accepted as a suitable alternative for tracheal tube. This airway is often an indication of patients who have difficulty with common intubation, or for whom intubation seems impossible. LMA insertion is more bearable in comparison to tracheal intubation in lower concentrations of anesthetic drugs. Furthermore, the complications of LMA including; hemodynamic changes, gagging, coughing, laryngospasm, throat wound, sore throat, and itchy throat are less than tracheal tube. To correctly insert LMA and prevent complications, sufficient depth of anesthesia and mouth opening areneeded . Increased sedation of patients and relaxation of jaw muscle makes insertion of this device easier . Although propofol is a selected induction drug of choice for LMA insertion, using only propofol does not provide a good condition for LMA insertion and can trigger unwanted reactions such as cough, hiccup, laryngospasm, and movement of the patient.To improve the condition of insertion, high doses of propofol that can weaken the cardiovascular system are needed.The application of dexmedetomidine in the anesthesia induction could reduce the propofol requirement by 38 % for facilitating LMA insertion without prolonged respiratory depression and hemodynamic instability . Although the utilization of muscle relaxantsin patients under positive pressure ventilation suppresses spontaneous breathing and attenuates the complications of ventilator , there is controversy over the effect of muscle relaxants in improving LMA insertion conditions. The objective of this study is to evaluate the effect of low‑dose atracurium on the time and easiness of insertion, complications, and hemodynamic responses to LMA insertion.
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 15/05/2023
Actual trial start date 15/05/2023
Anticipated date of last follow up 15/08/2023
Actual Last follow-up date 15/08/2023
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Muscle relaxation by small dose of atracurium induction of anesthesia for all patients included preoxygenation,1 µg/kg/ IV of dexmedetomidine over 10 minutes, 2 mg/kg/IV of propofol and 0.1 mg /kg/IV atracurium (in 2 ml volume) once before insertion of laryngeal mask airway (LMA) 0.1 mg atracurium/kg 20
Control Group saline to make the procedure blind induction of anesthesia for all patients included preoxygenation,1 µg/kg/ IV of dexmedetomidine over 10 minutes, 2 mg/kg/IV of propofol and IV 2 ml saline once before LMA insertion 2 ml saline 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients of both sex aged more than 18 years undergoing eye operations history of musculoskeletal diseases, history of hypersensitivity to the muscle relaxant drugs, pregnancy, the need for endotracheal tube during anesthesia, history of hiatal hernia, a gastric esophageal reflux history, and potential for difficult airway management based on physical examination 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 85 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 30/04/2023 Mansoura IRB
Ethics Committee Address
Street address City Postal code Country
algomhoreya Mansoura 35111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time of inserting LMA and ease of insertion after insertion of LMA
Secondary Outcome cardiovascular variables such as systolic and diastolic blood pressure after injection of anesthetic drugs, and 1 and 5 min after insertion and fixation of LMA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MUH algomhoreya Mansoura 35111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
my self gomhoreya mansoura 35111 Egypt
my self gomhoreya mansoura 35111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor MUH gomhoreya Mansoura 35111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Ghareeb sameh926@yahoo.com 00201005589289 gomhoreya
City Postal code Country Position/Affiliation
Mansoura 35111 Egypt Associate professor of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries May Badr mayelsherbiny@mans.edu.eg 00201007193959 gomhoreya
City Postal code Country Position/Affiliation
Mansoura 35111 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sameh Ghareeb sameh926@yahoo.com 00201005589289 gomhoreya
City Postal code Country Position/Affiliation
mansoura 35111 Egypt Associate professor of anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that will be shared is the individual participant data that underlie the results reported in this article,after deidentification (text,tables,figures and appendices) Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication 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
sameh926@yahoo.com 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