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.: PACTR201706002299143 Date of Approval: 17/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postoperative Delirium in Elderly
Official scientific title Postoperative Delirium in Elderly Patients Undergoing Elective Orthopedic Surgeries: Comparative Study between Dexmedetomidine and Haloperidol
Brief summary describing the background and objectives of the trial Delirium is a condition characterized by an acute cognitive decline, a fluctuating mental status, disturbance of consciousness, inattention, or disorganized thinking.Postoperative delirium (POD) can differ in some aspects from delirium that occurs in medical patients; delirium in medical patients occurs because of an acute illness or exacerbation of a chronic one, whereas surgical patients are supposed to have optimal physical condition before surgery. This study aimed to examine whether the intraoperative use of Dexmedetomidine was associated with a lower incidence of neurocognitive dysfunction in elderly patients undergoing elective orthopedic surgery when compared to Haloperidol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Musculoskeletal Diseases,Post operative delirium,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Comparative Study between Dexmedetomidine and Haloperidol
Anticipated trial start date 31/05/2017
Actual trial start date 31/05/2017
Anticipated date of last follow up 01/11/2018
Actual Last follow-up date 01/11/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status 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 Computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised 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
Control Group Group C I.V saline 20 Placebo
Experimental Group Group D 1 ¿g/kg over 20 minutes then continuous infusion at a rate of 0.4 ¿g/kg/h by a syringe pump maintained until end of surgery maintained until end of surgery dexmedetomidine 20
Experimental Group Group H 0.5 mg IV bolus followed by continuous infusion of 0.1 mg/h maintained until the end of surgery maintained until the end of surgery Haloperidol 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-III patients aged 65 years or more scheduled for orthopedic surgery. Patients refused to provide informed consent. Patients with Mini-Mental State Examination <24. Patients with diseases of the central nervous system. Patients with history of consumption of tranquilizers or antidepressants. Patients with severe visual or auditory handicap. Patients currently diagnosed with alcoholism or drug dependence. Patients of ASA grade IV (i.e., with coexisting severe cardiovascular, respiratory, renal or hepatic diseases). Patients with severe infections. Patients with severe anemia (hematocrit <30%). Patients with fluid or electrolyte disturbance including dehydration, hyponatremia , hypernatremia. 65 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 04/12/2016 Benha Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Fareed Nada street Benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Number of patients developed delirium The first postoperative day The second postoperative day The third postoperative day
Primary Outcome ¿ Degree or severity of postoperative delirium. The first postoperative day The second postoperative day The third postoperative day
Secondary Outcome Demographic characteristics: Age, Sex, ASA, weight. Before surgery
Secondary Outcome Duration of surgery. At the end of surgery
Secondary Outcome ¿ Hemodynamic variables: Mean arterial blood pressure (MAP) and heart rate (HR) Every 15 minutes intraoperative Every 30 minutes postoperative for 3 hours.
Secondary Outcome Visual analogue scale 6 hours after surgery 12 hours after surgery 24 hours after surgery 48 hours after surgery 36 hours after surgery 72 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha University Fareed Nada street Benha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha University Fareed Nada street Benha 13518 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha University Fareed Nada street Benha 13518 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Orthopedic department Fareed Nada street Benha 13518 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Sobhy menobambino@gmail.com +20-01008814570 Atreeb
City Postal code Country Position/Affiliation
Benha 13512 Egypt assistant lecturer of Anesthesia and I.C.U at Benha Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Saad Ibrahim saadibrahim_7@yahoo.com +20-01223142889 Oman street_ El Dokky
City Postal code Country Position/Affiliation
Cairo 12611 Egypt professor of anesthesia and I.C.U at Benha Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mostafa bashaahmad@yahoo.com +20-01005204130 Fareed Nada street
City Postal code Country Position/Affiliation
Cairo 12111 Egypt professor of anesthesia and I.C.U at Benha Faculty of Medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information