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.: PACTR201402000737691 Date of Approval: 07/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An approach to emergence agitation following hypotensive anesthesia in patients anesthetized with sevoflurane for functional endoscopic sinus surgery.
Official scientific title An approach to emergence agitation following hypotensive anesthesia in patients anesthetized with sevoflurane for functional endoscopic sinus surgery.
Brief summary describing the background and objectives of the trial Background Emergence agitation (EA) is a well-documented phenomenon in children anesthetized with sevoflurane (1, 2, and 3) however; EA has not been studied sufficiently in adults. Despite EA is time-limited, but it can substantially affect the patient and surrounding stuff; the agitated patient tries to remove IV cannulas, O2 mask, nasal pack therefore he subject himself to self-injury such as rebleeding, hypoxia and inability to receive medications. Furthermore, he can be dangerous to recovery room stuff by throwing objects and hitting them. We have recorded cases of bruises and ecchymosis from restrains of severely agitated patients In our pilot study, we have noted that patients recovering from hypotensive anesthesia and anesthetized with sevoflurane exhibits variable degrees of emergence agitation up to delirium. Some of them become more agitated if given midazolam or mepridine for sedation or pain control. We do not know if our protocol of medications and or hypotension is responsible for emergence agitation. We have planned a series of studies to prevent and understand EA following induced hypotension in adults. It is intuitively attractive to consider pre-operative administration of MG sulphate to prevent or ameliorate EA for several reasons; first, it can help in deliberate hypotension (4) therefore, reducing the dose of the used medication to control blood pressure that might increase agitation. Second, it antagonizes N-methyl ¿D Aspartate (NMDA) receptors (5,6) thus providing analgesia; third, it has a calming and anesthetic sparing effect (6). Aim of the study This study is designed to 1- study frequency and severity of EA related to hypotensive anesthesia in adults. 2- Study the effect of MG SO4 on prevention of EA in comparison to placebo control.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative agitation and delerium,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/02/2014
Actual trial start date 04/02/2014
Anticipated date of last follow up 04/08/2014
Actual Last follow-up date 04/08/2014
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 312
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 randomised by research randomizer computer generated programme central randomization by using the phone will be used after patient enrollment to assign group Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control 20 ml normal saline one hour starting infusion prior to induction 150 Placebo
Experimental Group magnisium sulphate 30mg/kg diluted in 20 ml normal saline for one hour starting infusion prior to induction 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II patients, both male and female who will undergo functional endoscopic sinus surgery a- age below 20 or above 60 b- Hypertensive patients c- Cardiac ischemia d- Cerebral or renal insufficiency patients e- Known allergy to MG sulphate f- History of neuromuscular disease g- Prior anticoagulation h- Diabetic neuropathy i-Pregnancy j- Prior treatment with calcium channel blockers 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 06/01/2014 Menoufia university hospitals,ethics committee for clinical research
Ethics Committee Address
Street address City Postal code Country
Gamal abdel-nasser street, Shebin Elkom,Menoufia Egypt Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence and severity of emergence agitation 1-immidiate postoperative 2- 5 minutes after recovery 3-10minutes after recovery 4-15 minutes after recovery 5- 30 minutes after recovery
Secondary Outcome pain score immediate postoperative, 5minutes after operation,10 minutes,15 minutes and 30 minutes after operation when feasible
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya university Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hazem Elsersy 89 saad Zagloul street Shebin Elkom, Menoufia NA Egypt
Magdy chehata metyas Nasr city Cairo NA Egypt
Hanaa fetoh Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
Abdel bassit Hassan Abu bakr Alsedeek street Cairo NA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem Elsersy hazelsersy@hotmail.com 00201222598999 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
Role Name Email Phone Street address
Public Enquiries Abdel Bassit Hassan bassit60md@gmail.com 009660554361312 Nasr city
City Postal code Country Position/Affiliation
Cairo NA Egypt assistant professor of ENT surgery Alazhar University
Role Name Email Phone Street address
Scientific Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201222598999 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
REPORTING
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