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.: PACTR201403000768165 Date of Approval: 07/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title I gel supraglottic device for prone anesthesia
Official scientific title I gelTM for conduction of controlled general anesthesia in the prone position: A prospective randomized trial
Brief summary describing the background and objectives of the trial Background: Airway maintenance during anesthesia in the prone position is a vital process for anesthetists. Tracheal intubation, remains the approach of choice. Turning an unconscious intubated patient into the prone position is critical. Self-positioning may reduce the risk of transfer-related complications to an unconscious patient. Supraglottic airway device like i-gel may be an alternative option in such procedures. Methods: After ethical approval and written informed consent, One hundred patients were selected to undergo controlled general anesthesia in the prone position. Patients were divided randomly using a closed envelope method into two groups: ¿ Group I (ETT gp): Induction and recovery was done in the supine position. Airway was maintained via an endotracheal tube. ¿ Group II (I-gel gp): Induction and recovery was done in the prone position Airway was maintained via an i-gelTM. Results: Hemodynamics increased statistically significantly after intubation in the ETT group compared to the i-gel group and before skin incision where the mean arterial blood pressure decreased statistically significantly in the ETT. No significant differences were noticed regarding ventilatory parameters. Time of readiness to surgery and time of discharge from OR was statistically significantly lower in the i-gel compared to the ETT group (p 0.001). I-gel was successfully inserted in all patients from the 1st time. Conclusion: I-gel in the prone position is effective in management of the airway in such position and may be an effective component of ambulatory anesthesia for short surgical procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,anesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 23/12/2012
Actual trial start date 23/12/2012
Anticipated date of last follow up 19/08/2013
Actual Last follow-up date 27/08/2013
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 randomisation table Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group i-gel group once less than one hour to anesthetise patients in the prone position using i-gel 50 Active-Treatment of Control Group
Experimental Group I-gel in the prone position Once Less than one hour To anesthetise patients in the prone position using I-gel 50
Control Group Endotracheal intubation once less than one hour to anesthetise patients in the prone position using endotracheal tube 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age from 20 - 60 years. ¿ ASA class I - II. ¿ Short surgical procedures in the prone position not lasting more than one hour. predicted difficult airway, mouth opening < 2.5 cm, Body mass index > 30 kg.m-2 patients at risk of regurgitation of gastric contents. 20 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 19/11/2012 Alexandria faculty of medicine, clinical research center
Ethics Committee Address
Street address City Postal code Country
Alsultan Hussein Alexandria 21615 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time taken for each patient to be ready and be discharged from the operative theatre Time of readiness of patients to surgery Defined as the time lapse from entry of the patient to the operative room to readiness for disinfection and draping. Time to full discharge from the operative room Defined as the time lapse from the end of the surgical procedure to discharge of the patient from the operative room.
Secondary Outcome Hemodynamic variations, success of ventilation and airway and position related morbidity ¿ Before induction. ¿ After induction. ¿ After insertion of the airway device. ¿ Before skin incision. ¿ Immediately after skin incision. Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria faculty of medicine Alsultan Hussein Alexandria 21615 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria faculty of medicine Alsultan Hussein Alexandria 21615 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria faculty of medicine Alsultan Hussein Alexandria 21615 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Alnasr street Alexandria 21615 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Abdelaziz m.3abdelaziz@hotmail.com +201222373407 Alnasr street
City Postal code Country Position/Affiliation
alexandria 21615 Egypt lecturer in anesthesia
Role Name Email Phone Street address
Public Enquiries Maha Ghanem alexmedethics@yahoo.com +201287740750 Alsultan Hussein
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Chairman of Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com +201223368233 Alsultan Hussein
City Postal code Country Position/Affiliation
alexandria 21615 Egypt professor 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