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.: PACTR201601001413311 Date of Approval: 06/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Air-Q Laryngeal Mask Versus Endotracheal Intubation During Hypotensive Anesthesia For Middle Ear Surgery
Official scientific title Air-Q Laryngeal Mask Versus Endotracheal Intubation During Hypotensive Anesthesia For Middle Ear Surgery
Brief summary describing the background and objectives of the trial Fifty patients were randomly allocated into two groups using a sealed envelope method (25patients for each group):Group T: in whom airway was secured by endotracheal tube.Group Q: in whom airway was secured by Air-Q laryngeal mask. Following routine pre-oxygenation, anesthesia was induced using fentanyl 3 ¿g.kg¿1 followed by propofol 2 mg.kg¿1, a non-depolarizing muscle relaxant (atracurium 0.5 mg.kg¿1) was used to produce neuromuscular blockade. Blood pressure and heart rate were monitored immediately following induction of anaesthesia, immediately after intubation,then every 5 min after intubation till the end of operation. The systolic, diastolic and mean values of blood pressure and heart rate were recorded. Nitroglycerin infusion rates were adjusted in order to maintain mean blood pressure between 60-70 mmHg and propranolol shots to keep Heart rate between 70-80 beats per minute. The total Nitroglycerin infusion rates and propranolol doses needed to achieve our previously mentioned values of blood pressure and heart rate were reported by the end of the surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Ear, Nose and Throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 19/05/2013
Actual trial start date 19/05/2013
Anticipated date of last follow up 18/11/2014
Actual Last follow-up date 18/11/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group endotracheal tube 1 during the surgery observation 25 Active-Treatment of Control Group
Control Group Air-Q laryngeal mask 1 during the surgery observation 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients aging 18-60 years. - Patients undergoing elective middle ear surgery. - ASA physical status ¿ and ¿¿. -History or suspected difficult airway. -ASA physical status III and IV. -History of uncontrolled Hypertension,Myocardial Ischemia, uncontrolled Diabetes Mellitus and cerebrovascular stroke. -Renal disease, liver dysfunction, pregnancy and hypovolemia. -BMI ¿ 30 . 18 Year(s) 60 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 14/04/2013 FM- BSU REC
Ethics Committee Address
Street address City Postal code Country
bni suif bni suif Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome blood pressure following induction of anaesthesia (post-induction values), immediately after intubation,then every 5 min after intubation till the end of operation
Secondary Outcome heart rate following induction of anaesthesia (post-induction values), immediately after intubation,then every 5 min after intubation till the end of operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine bni suif bni suif Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
bni suif university bni suif bni suif Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor bni suif university bni suif bni suif Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed mahran mohamed mtwly giza Egypt
ahmed A.Aal nsr city cairo Egypt
Kerollos Moneer a bni suif bni suif Egypt
Mahmoud M. Amer nsr city cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed mahran mali7511@yahoo.com 01006945585 mohamed mtwly
City Postal code Country Position/Affiliation
giza Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries ahmed A.AL Aal carnitine7@yahoo.com 01113308866 nsr city
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries mohamed mahran mali7511@yahoo.com 01006945585 mohamed mtwly
City Postal code Country Position/Affiliation
giza Egypt lecturer of anesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information