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.: PACTR201412000962379 Date of Approval: 06/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Remifentanil versus dexmedetomidine
Official scientific title A comparison of risk of hypotension using standard doses of remifentanil versus dexmedetomidine infusions, in adult patients undergoing elective surgery under general anaesthesia at the Aga Khan University Hospital, Nairobi.
Brief summary describing the background and objectives of the trial Background Remifentanil and dexmedetomidine are common agents used in general anaesthesia, monitored anaesthesia care and critical care. Remifentanil is a piperidine derivative and a short acting opioid. Dexmedetomidine is an alpha two selective agonist. When combined with inhaled or intravenous anaesthestic agents intraoperatively, they provide analgesia, lower general anaesthetic requirements and provide sedation and analgesia in the perioperative period if indicated. Therapeutic doses are achieved through defined ranges of infusions. These two drugs have different mechanism of actions, pharmacokinetic properties but commonly provide analgesia and sedation. Pharmacodynamically, they cause hypotension and bradycardia which are reversible and well managed. Hypotension is a common side effect experienced in general anaesthesia. Studies have shown high proportion of hypotension when compared with similar agents and in isolation. This study compares these two drugs on the effect of hypotension when used as adjuncts to general anesthesia at low dose standard rate of infusions. Primary Objective To compare the proportion of hypotension episodes in a group of adult patients receiving dexmedetomidine infusion at 0.4mcg/kg/hr compared to a group receiving remifentanil infusion at 0.2mcg/kg/min. Secondary Objective 1. To compare the severity of first episode of hypotension in adult patients receiving dexmedetomidine infusion compared to those receiving remifentanil infusion. 2. To compare the number of physician interventions in each group
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Hypotension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial physician interventions
Anticipated trial start date 01/05/2014
Actual trial start date 01/09/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 96
Recruitment status Recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
2014 rec-14 The Aga Khan University, Hairobi Health Research Committee
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine infusion standard dose of 0.4 mcg/kg/hr duration of surgery patients are to receive dexmedetomidine at a standrad infusion rate of 0.4mcg/kg/hour during the duration of surgery and compared against a group receiving remifentanil at 0.2 mcg/kg/min 48
Control Group Remifentanil infusion standard dose of 0.2.mcg/kg/min duration of surgery patients are to receive remifentanil infusion at a standard rate of 0.2 mcg/kg/min during the duration of surgery and compared against the intervention group receiving dexmedetomidine infusion at 0.4mcg/kg/hour 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II patients Patients aged 18-85 years Elective surgical procedures BMI >35 Pregnant women Patients with severe liver and renal dysfunction Patients diagnosed to have mental disorders Pre-existing bradycardia and brady-dysrhythmia Cardiovascular insufficiency and valvular heart disease Hypertensive patients 18 Year(s) 85 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 22/08/2014 The Aga Khan University, Nairobi Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, P.O. BOX 30270 NAIROBI 0100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hypotension Number of episodes of hypotension from the start of surgical incision to the end
Secondary Outcome severity of hypotension measured with each episode of hypotension at the beginning of the surgical incision to the very end
Secondary Outcome number of physician interventions during each time, the number of physician interventions shall be counted and analysed i.e. fluid boluses given, vasopressor support, titration of the infusion and termination of the infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aga Khan University Hospital, Nairobi 3RD PARKLANDS AVENUE, P.O. BOX 30270-00100 NAIROBI 0100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Aga Khan University, Faculty of Health Sciences research committee 3RD PARKLANDS AVENUE, P.O. BOX 30270-00100 NAIROBI 0100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Aga Khan University, Faculty of Health Sciences research committee 3RD PARKLANDS AVENUE, P.O. BOX 30270-00100 NAIROBI 0100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
The Aga Khan University Hospital, Nairobi 3RD PARKLANDS AVENUE, P.O. BOX 30270-00100 NAIROBI 0100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maxine Okello maxineagina@gmail.com +254722600737 3RD Parkalands Avenue, P.O. BOX 30270
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Resident in Anaesthesia MMed Program
Role Name Email Phone Street address
Public Enquiries Ciiru Kamanda kamanda.ciiru@aku.edu +254203662107/2109 3RD Parkalands Avenue, P.O. BOX 30270
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Research Unit Co-ordinator
Role Name Email Phone Street address
Scientific Enquiries vitalis mung'ayi mung'ayi.vitalis@aku.edu +254711092158 3RD Parkalands Avenue, P.O. BOX 30270
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Content Supervisor of research study
Role Name Email Phone Street address
Scientific Enquiries Rodney Adams adams.rodney@aku.edu +254711092000 3RD Parkalands Avenue, P.O. BOX 30270
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Methodology Supervisor of research study
REPORTING
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