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.: PACTR201701001959580 Date of Approval: 03/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sedation during Awake Fiberoptic Intubation
Official scientific title A Comparative Study of Intravenous Dexmedetomidine¿versus Ketofol for Sedation during Awake Fiberoptic Intubation
Brief summary describing the background and objectives of the trial Intubation in patients with a laryngeal mass may present a great challenge to anesthesiologists. Sometimes tracheostomy is not available,so the safest technique to secure the airway is using a fiberoptic bronchoscope Adequate topical anesthesia and sedation are important during Awake fiberoptic intubation (AFOI) in order to maintain the patient's airway and minimize discomfort. Optimal technique should enable the patients to be cooperative, comfortable and have blunted airway reflexes.A number of agents have been used for sedation during AFOI. Airway blocks are usually performed on sedated, spontaneously ventilating patients. Propofol is a sedative with a quick onset and short recovery time. It has also an anti-emetic, anticonvulsant, antipruritic and amnestic effects. But its use is limited by a relatively high incidence of dose-dependent hypotension and respiratory depression. Ketamine provides excellent amnesia and analgesia, preserves muscle tone with maintaining airway reflexes and spontaneous respiration. But it has some disadvantages like sympathomimetic effects, hallucinations, vomiting and excessive salivation.Combination of propofol and ketamine has many advantages as it preserves haemodynamic stability, relieves hallucinations, analgesia,amnesia, airway preservation, maintenance of spontaneous respiration and rapid recovery.Dexmedetomidine is a selective adrenergic ¿2 agonist. It has sedative and analgesic properties.Contrary to other sedatives, dexmedetomidine does not cause respiratory depression no data are available comparing dexmedetomidine and sedation with ketofol during awake fibreoptic intubation.This study was designed as randomized controlled trial to compare safety and efficacy of dexmedetomidine and ketofol administration during awake fibreoptic intubation as regards hemodynamic variables, oxygen saturation (primary goal) , endoscopy and intubation times, and patients' and anesthesiologists¿ satisfaction (secondary goal).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AFOI
Disease(s) or condition(s) being studied laryngeal mass,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 25/06/2016
Actual trial start date 15/07/2016
Anticipated date of last follow up 25/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 92
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethics Committee, Tanta University, Facualty of Medicine Approval code: 30663/12/15
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly table allocated into two equal groups; group Dex ( Dexmedetomidine group), group KP (Ketofol group) by using sealed opaque envelope technique; the envelope will be open by another investigator who has no role in the study. sealed opaque envelope technique Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group dexmedetomidine 1 mic/kg as intravenous bolus dose followed by 0.2 mic/kg/h titrated up to 0.7 mic/kg/h till reach Ramsay sedation scale >2 Dexmedetomidine is given after nasal airway is inserted and connected to breathing circuit to administer 100% oxygen 46 Active-Treatment of Control Group
Experimental Group Ketofol propofol ketamine mixture in a ratio of 3:1 respectively and 0.05 ml/kg is given then 0.025 ml/kg for subsequent doses( each ml of ketofol contains 7.5 mg propofol &2.5 mg ketamine) till till reach Ramsay sedation scale >2 Ketofol is given after nasal airway is inserted and connected to breathing circuit to administer 100% oxygen 46
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18-60 years old both sex ASA I,II and III Laryngeal mass biopsy under general anesthesia Patient refusal Uncooperative patients. Emergency surgery Patients with hypersensitivity to any of drugs of the study. Addiction or patients on long term sedative medication. Pregnant women. 7- Body mass index more than 35 Kg/m2. 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 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish st Tanta/Gharbia 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemodynamic variables and oxygen saturation Heart rate, mean arterial blood pressure, and arterial oxygen saturation recorded at the following points: on arrival to the operating room as a baseline after bolus sedation immedi¬ately prior to fiberoptic intubation at the passage of the fiber-optic endoscope through vocal cords at time of intubation, then at 1,3,5 minutes after intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital, Facualty of Medicine El-Geish st Tanta/Gharbia 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The researchers responsible for this work fund. Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Elsayed Afandy Elgeish st Tanta/Gharbia 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elsayed Afandy El-Geish st Tanta/Gharbia 31257 Egypt
Radwa Fathy Mansour El-Geish st Tanta/Gharbia 31257 Egypt
Mona Raafat El Ghamry El-Geish st Tanta/Gharbia 31257 Egypt
Mona Blough Elmourad Fayad El-Geish st Tanta/Gharbia 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Afandy Mohamedafandy811@yahoo.com 01225131526 Elgeish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com 01060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt
Role Name Email Phone Street address
Scientific Enquiries Mona Fayad monamorad80@gmail.com 01225124747 Elgeish st.
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt
REPORTING
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