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.: PACTR201601001412346 Date of Approval: 06/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Two Different Remifentanil Doses On Stress Response And Awareness During Modified Rapid Sequence Induction
Official scientific title Effect of Two Different Remifentanil Doses On Stress Response And Awareness During Modified Rapid Sequence Induction
Brief summary describing the background and objectives of the trial Modified rapid sequence induction was started with Remifentanil in a prefilled 10 ml syringe bolus dose over 30 seconds followed by Propofol 1.5 mg/kg then Rocuronium 1 mg/kg and intubation was done 1 minute after injection of Rocuronium. Hemodynamic parameters including heart rate (bpm), systolic, diastolic and mean arterial blood pressure (mm Hg) and BIS value were recorded before induction (this represent baseline), after induction, at intubation (During laryngeoscopy ) and at 1, 3, 5 and 10 minutes following intubation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/02/2014
Actual trial start date 02/02/2014
Anticipated date of last follow up 10/12/2014
Actual Last follow-up date 10/12/2014
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmetidomedine 1 µg / kg bolus observation 40 Dose Comparison
Experimental Group dexmetidomedine 0.75 µg / kg bolus observation 40 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II , Age group18-60 years old Body mass index (BMI) < 30 Patients with hypersensitivity to Remifentanil , Propofol or Rocuronium , severe renal or hepatic disease , severe cardiac dysfunction , hypertension , muscle disease and expected difficult intubation 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 15/12/2013 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 increase in heart rate, blood pressure before induction (this represent baseline), after induction, at intubation (During laryngeoscopy ) and at 1, 3, 5 and 10 minutes following intubation
Secondary Outcome BIS before induction (this represent baseline), after induction, at intubation (During laryngeoscopy ) and at 1, 3, 5 and 10 minutes following intubation
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
Secondary Sponsor mohamed a. mahran mohmed mtwly giza Egypt Hospital
Primary Sponsor bni suif university bni suif bni suif Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed a. mahran mohmed mtwly giza Egypt
hazem a. wahab 61B bni suif bni suif Egypt
Ahmed A.Aal nsr city cairo Egypt
Ahmed EL Souly bni suif bni suif 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 hazem a.wahab hazemwahab@yahoo.com 01153517862 61b bni suif
City Postal code Country Position/Affiliation
bni suif 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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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