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.: PACTR201610001637385 Date of Approval: 18/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF LOW-DOSE KETAMINE VERSUS FENTANYL ON ATTENUATING THE HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN PATIENTS UNDERGOI
Official scientific title A RANDOMIZED CONTROL TRIAL COMPARING THE EFFECT OF LOW-DOSE KETAMINE VERSUS FENTANYL ON ATTENUATING THE HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN PATIENTS UNDERGOING GENERAL ANAESTHESIA AT THE AGA KHAN UNIVERSITY HOSPITAL, NAIROBI
Brief summary describing the background and objectives of the trial The mechanisms of post laryngoscopy/intubation haemodynamic response include a somatovisceral reflex, stimulation of proprioceptors at the base of the tongue with catecholamine release and vagal inhibition of the heart. This provokes a haemodynamic response characterized by an increase in heart rate and blood pressure. A 2013 Cochrane review of 72 RCTs suggests that even low risk (ASA I/II) patients are susceptible to cardiac arrhythmia and ECG evidence of myocardial ischaemia as a consequence of haemodynamic changes related to tracheal intubation. It remains unclear what the long-term impact on health this pressor response has. Many drugs intended to attenuate this pressor response have been studied, and they present their own array of drawbacks. Fentanyl is commonly used in the institution where I practice and I sought to find and equi-effective and widely available alternative to opioids. This would enable use in patients where opioid use would be undesirable (e.g. GA for CS, need to avoid respiratory depression-difficult airway). Ketamine is a potent analgesic and its cardio-stimulatory effect is minimal to nil at sub-anaesthetic/analgesic doses. this is demonstrated well by it's use in managing tourniquet pain (manifested by hypertension and tachycardia) whereby hypertension and tachycardia resolves. I sought to see if at analgesic doses, ketamine would attenuate the haemodynamic response to laryngoscopy and endotracheal intubation (choosing a dose where it's own cardiostimulatory effects are known to be minimal). Primary Objective: To compare the effect of low-dose ketamine versus fentanyl on the incidence of hypertension in patients undergoing general anaesthsia. Secondary Objective : i)To compare the incidence of tachycardia between the two study groups. ii)To compare the incidence of pre-laryngoscopy and intubation hypotension between the two study group
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date 06/11/2015
Anticipated date of last follow up 31/01/2016
Actual Last follow-up date 31/03/2016
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 108
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 randomisation table created by a computer software program 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 Ketamine 0.5mg/kg stat administration of ketamine (versus fentanyl) at induction 55
Control Group Fentanyl 1mcg/kg stat use at induction of general anaesthesia 53
Control Group Fentanyl 1microgam per kilogram Stat Drug administered at induction 54 Active-Treatment of Control Group
Experimental Group Ketamine 0.5milligrams per kilogram Stat Drug administered at induction 54
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ ASA I and II patients 18-65 years scheduled for non-emergent surgery. ¿ History of allergy or contraindications to any of the study drugs ¿ Patients scheduled for emergency surgery ¿ Hypertension ¿ i.e. a known/previously diagnosed hypertensive as per the American Heart Association guidelines ¿ Pregnancy ¿ Known ischaemic heart disease ¿ Known raised intracranial pressure or intracranial pathology where a rise in intracranial pressure would pose a risk or patients scheduled for neurosurgical procedures ¿ History, indicator (Mallampati score) of or proven difficult ventilation/laryngoscopy/intubation ¿ Intubation time greater than 30 seconds 18 Year(s) 65 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 05/11/2015 Research Ethics Committe, Aga Khan University, Nairobi
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 00100 GPO Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome occurrence of increase in systolic blood pressure (20% increase from baseline) 0 minutes 1 minute 2.5 minutes 5 minutes 7.5 minutes 10 minutes
Secondary Outcome occurrence of decrease in systolic blood pressure (20% decrease from baseline) 0 minute 1 minute 2.5 minutes 5 minutes 7.5 minutes 10 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hopsital 3rd Parklands Avenue Nairobi 00100 GPO Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 GPO Kenya
Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 GPOk
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AGa Khan University, Nairobi 3rd Parklands Avenue Nairobi 00100 GPO Kenya University
COLLABORATORS
Name Street address City Postal code Country
Aga Khan University 3rd parklands Avenue Nairobi 00100 GPO Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angela Ongewe angela.ongewe@gmail.com +254-723-624595 3rd Parklands Avenu
City Postal code Country Position/Affiliation
Nairobi 00100 GPO Kenya Resident Anaesthsiology
Role Name Email Phone Street address
Principal Investigator Angela Ongewe angela.ongewe@gmail.com +254-723-624595 3rd Parklands Avenu
City Postal code Country Position/Affiliation
Nairobi 00100 GPO Kenya Resident Anaesthsiology
Role Name Email Phone Street address
Public Enquiries Vitalis Mung'ayi vitalis.mung'ayi@aku.edu +254-724-904010 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 GPO Kenya Faculty Department of Anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries Rajpreet Bal rajbal@gmail.com +254-738-496298 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 GPO Kenya Faculty Department of Anaesthesiology
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