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.: PACTR201402000718234 Date of Registration: 03/12/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tourniquet Hypertension
Official scientific title A RANDOMISED CONTROL TRIAL TO ASSESS THE EFFECT OF A KETAMINE INFUSION ON TORNIQUET HYPERTENSION DURING GENERAL ANAESTHESIA IN PATIENTS UNDERGOING UPPER AND LOWER LIMB SURGERY.
Brief summary describing the background and objectives of the trial Background Tourniquet hypertension arising from tourniquet inflation remains of primary concern to the anaesthetist. One drug commonly used to manage tourniquet hypertension is ketamine. Several studies show that ketamine attenuated the blood pressure rise associated with tourniquet inflation. None of the studies carried out examined the effect of ketamine on tourniquet hypertension for a period of more than one hour or an infusion of the same. Primary objective ¿To compare the effect of an intravenous infusion of ketamine versus placebo on the incidence of tourniquet induced hypertension in patients undergoing upper and lower limb surgery under general anaesthesia Secondary objectives ¿To assess heart rate changes associated with tourniquet use ¿To assess the efficacy of ketamine on post-operative tourniquet pain ¿To determine the incidence of side effects associated with ketamine
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery,Tourniquet hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/10/2012
Actual trial start date 03/12/2012
Anticipated date of last follow up 11/03/2013
Actual Last follow-up date 08/03/2013
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a randomisation table crated by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ketamine infusion bolus of 0.1mg/kg then an infusion of 2ug/kg/min duration of tourniquet application Ketamine infusion to blunt tourniquet hypertension 23
Control Group saline group saline in a 10cc syringe given as a calculated dose of 0.1mg/kg followed by an infusion of 2ug/kg in a 20cc syringe as calculated for the experimental group duration of tourniquet application saline used as placebo to see the effect of ketamine on tourniquet hypertension 23 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿American Society of Anaesthesiologists (ASA) physical status I and II patients ¿Patients undergoing elective and emergency orthopaedic surgery with tourniquet application under general anaesthesia ¿ASA physical status III and above ¿Age below 18yrs and above 70 yrs ¿Pregnant women ¿Surgery performed under regional anaesthesia ¿Patients with hypertension, ischaemic heart disease and diabetes mellitus ¿Patients with dementia or a history of a psychiatric illness ¿Patients who refuse to give consent 18 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 Aga Khan University Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
00100 Nairobi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intra- operative blood pressure changes from baseline values before general anaesthesia 5 min after general anaesthesia 5 min after tourniquet inflation and 10 min thereafter until tourniquet deflation
Secondary Outcome heart rate changes associated with tourniquet use, efficacy of ketamine on post-op pain and incidence of side effects associated with ketamine use -before general anaesthesia 5 min after general anaesthesia 5 min after tourniquet inflation and 10 min thereafter until tourniquet deflation -post-operatively -post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue Nairobi 00100 (30270) Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital Research fund 3rd Parklands Avenue Nairobi 00100 (30270) Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Hospital Research fund 3rd Parklands Avenue Nairobi 00100 (30270) Kenya University
Secondary Sponsor Self 3rd Parklands Avenue Nairobi 00100 (30270) Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr. Vitalis Munga'yi 3rd Parklands Avenue Nairobi 00100 (30270) Kenya
Dr. Jimmy kabugi 3rd Parklands Avenue Nairobi 00100 (30270) Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joyce Ongaya ongaya.joyce@aku.edu 0722841970 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100- 30270 Kenya Resident
Role Name Email Phone Street address
Public Enquiries Ciru Kamanda kamanda.ciru@aku.edu +254203662958 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100- 30270 Kenya Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Jimmie Kabugi jimmie.kabugi@aku.edu 0722790237 3rd Parklands Avenue
City Postal code Country Position/Affiliation
nairobi 00100- 30270 Kenya Consultant cardiac anaesthesia
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