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.: PACTR201712002863123 Date of Approval: 12/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Different doses of dexmedetomidine for conscious sedation during awake nasotracheal fiberoptic intubation fiberoptic
Official scientific title Comparative study of multiple doses regimen of Dexmedetomidine used for moderate sedation facilitating intubation condition during nasotracheal fiberoptic laryngoscope in awake patients. Randomized prospective study.
Brief summary describing the background and objectives of the trial nasal fiberoptic intubation in fully conscious patients was the most suitable airway technique of choice in known or unexpected difficult airway, cervical deformities, restricted mouth cavity exposure and any facial deformities. Both optimal intubating circumstances and patient tolerance were the major important values for fiberoptic intubation. Optimal intubating conditions provided by an ideal sedation regimen would maintain hemodynamics stability, patient comfort, attenuation of upper airway reflexes and amnesia. Aim: To detect variant efficiency of different dose regimen of dexmedetomidine used for conscious sedation facilitating intubation condition by using nasotracheal fiberoptic laryngoscope in awake patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,patient comfort, intubating condition and hemodynami stability during conscious sedation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 01/06/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
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 from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I: patients received I.V. Dexmedetomidine 1 microg a a bolus followed by 0.7microg/kg/h throughout the manipulation 20
Experimental Group Group IIpatients received I.V. Dexmedetomidine 0.7µg/kg as a bolus dose slowly over ten minutes then 0.2µg/kg/h as a maintenance dose by a syringe pump throughout the manipulation 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with ASA patients status I and II Patients with obesity more than 30% above the ideal body weight, patients refusal,gastroesophageal reflux, uncontrolled blood pressure, ischemic heart diseases, diabetic, asthmatic, severe bradycardia or any type of A-V block on ECG,coagulapthy, hepatic, renal dysfunction thrombocytopenia, hyperactive air way diseases, , history of drug maluse,and a long term use of benzodiazepines or antidepressant drugs, any neurological disorders or mental retardation, pregnancy, nasal polyp, history of allergy to any used medication, any apparent airway abnormalities with mallampati score ¿ III(7), thyromental distance ¿ 6 centimeters and history of laryngeal or pharyngeal surgeries all were excluded from our study. 30 Year(s) 70 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 01/12/2017 Aswan University
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Observer¿s Assessment of Alertness and Sedation Scale (OAA/S) and level of discomfort during nasal fiberoptic intubation before start of study medication and every 2 min during airway maneuvers.On the first postoperative day
Secondary Outcome ). Hemodynamic parameters including Heart Rate (HR), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), SpO2 and EtCO2 were also detected during preoxygenation, fiberscope insertion (1, 2, 3, 4, 5and 8 min. intervals) and endotracheal intubation(1, 2, 3, 4, 5and 8 min. intervals) during preoxygenation, fiberscope insertion (1, 2, 3, 4, 5and 8 min. intervals) and endotracheal intubation(1, 2, 3, 4, 5and 8 min. intervals)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Daculty of Medicine Aswan University el Seel Street Aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Aswan University El Seel Street Aswan 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Aswan University El Seel Street Aswan 35127 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sherif Kamal Arafa El Bahr Street Tanta 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 35127 Egypt Lecturer of Anesthesia, ICU, Aswan University
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 35127 Egypt Lecturer of Anesthesia, ICU, Aswan University
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com 01005714014 El Bahr Street
City Postal code Country Position/Affiliation
Tanta 35127 Egypt Lecturer of Anesthesia, ICU, Aswan University
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
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