|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201412000962379 |
|
Date of registration:
|
06/12/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Remifentanil versus dexmedetomidine
|
|
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. |
|
Date of first enrolment:
|
01/05/2014 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=962 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Kenya
| | | | | | | |
|
Contacts
|
|
Name:
|
vitalis
mung'ayi |
|
Address:
|
3RD Parkalands Avenue, P.O. BOX 30270
00100
NAIROBI
Kenya |
|
Telephone:
|
+254711092158 |
|
Email:
|
mung'ayi.vitalis@aku.edu |
|
Affiliation:
|
Content Supervisor of research study |
|
|
Name:
|
Ciiru
Kamanda |
|
Address:
|
3RD Parkalands Avenue, P.O. BOX 30270
00100
NAIROBI
Kenya |
|
Telephone:
|
+254203662107/2109 |
|
Email:
|
kamanda.ciiru@aku.edu |
|
Affiliation:
|
Research Unit Co-ordinator |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: ASA I or II patients
Patients aged 18-85 years
Elective surgical procedures
Exclusion criteria: 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
Age minimum:
18 Year(s)
Age maximum:
85 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Circulatory System
|
Circulatory System
Hypotension
|
|
Hypotension
|
|
Intervention(s)
|
|
Dexmedetomidine infusion
|
|
Remifentanil infusion
|
|
|
|
Primary Outcome(s)
|
|
hypotension
|
|
Secondary Outcome(s)
|
|
number of physician interventions
|
|
severity of hypotension
|
|
Secondary ID(s)
|
|
2014 rec-14
|
|
Source(s) of Monetary Support
|
|
The Aga Khan University, Faculty of Health Sciences research committee
|
|
Ethics review
|
Status: Approved
Approval date: 22/08/2014
Contact:
The Aga Khan University, Nairobi Health Research Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|