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.: PACTR202208813896934 Date of Approval: 11/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of different doses of dexmedetomidine on intraoperative hemodynamic profiles and postoperative pain in patients undergoing abdominal surgery: a randomized controlled trial
Official scientific title Effectiveness of different doses of dexmedetomidine on intraoperative hemodynamic profiles and postoperative pain in patients undergoing abdominal surgery: a randomized controlled trial
Brief summary describing the background and objectives of the trial Dexmedetomidine is the highly selective α2-adrenergic agonist, which provides sedation, anxiolysis, hypnosis, analgesia, and sympatholysis. Dexmedetomidine provides a unique type of sedation, in which patients appear to be sleepy but are easily aroused, cooperative and communicative when stimulated. It possesses anxiolytic and moderate analgesic effects and causes minimal respiratory depression, even when given in larger doses of 2 µg/kg. Different from most clinically used anesthetics, dexmedetomidine brings about not only a sedative-hypnotic effect via an action on a single type of receptors but also an analgesic effect and an autonomic blockade that is beneficial in cardiac risk situations. Though it is widely used in clinical practice, dose-related potency and the right time to use this drug are still unclear. The main objective of this study is to investigate the effectiveness of different doses of dexmedetomidine on intraoperative hemodynamic profiles and postoperative pain in patients undergoing abdominal surgery at Dilla University referral hospital
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 30/12/2023
Anticipated target sample size (number of participants) 99
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 1 for 24 hours Group `A` Normal saline (NS), a placebo group, will be infused with a volume-matched in a similar preparation. 33 Placebo
Experimental Group group 2 for 24 hours Group `B` - dexmedetomidine weight-based doses of 0.4 µg/kg/hr will be infused 33
Experimental Group Group 3 for 24 hours Group `C` - dexmedetomidine weight-based doses of 0.6 µg/kg/hr will be given 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ASA I and II - age 18-65 yrs - patients with a history of PONV, motion sickness, gastroparesis, bradycardia, atrioventricular block, and severe cardiac dysfunction, diabetes, hypertension, coronary heart disease, liver, and kidney function seriously damaged, chronic pain, chronic opioid users, upper respiratory tract infection, asthma, smoking Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 04/01/2022 IRB of Dilla University college of health sciences and medicine
Ethics Committee Address
Street address City Postal code Country
Dilla, Ethiopia Dilla 13 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary endpoints will be to investigate the effect of different doses of dexmedetomidine infusion on hemodynamic response to critical incidences such as laryngoscopy, endotracheal intubation, surgical incision, and extubation in patients undergoing open abdominal surgery. A change in hemodynamic parameters (MAP, SBP, and HR) from baseline will be compared to the subsequent repeated measurements. intraoperatively
Secondary Outcome Our secondary endpoints are to observe the effects on extubation time, post-operative sedation levels in the PACU, postoperative nausea and vomiting, postoperative pain score and analgesic requirements, time to first analgesic request, and occurrence of adverse effects. Postoperative analgesia therapy will be provided when patients complain of pain (request medication) or a numeric rating scale≥of 4 is recorded. The analgesic drugs administered will be as per the hospital protocol. Within 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral Hospital Dilla, Ethiopia Dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Seyoum Hailu Dilla Dilla Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla, Ethiopia Dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Teshome Regasa Dilla Dilla Ethiopia
Darartu Neme Dilla Dilla Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyoum Hailu seyoumhailu44@gmail.com +251968060649 Dilla, Ethiopia
City Postal code Country Position/Affiliation
Dilla Ethiopia Principal Investigator
Role Name Email Phone Street address
Public Enquiries Teshome Regasa teshregasa32@gmail.com +251910563710 Dilla, Ethiopia
City Postal code Country Position/Affiliation
Dilla Ethiopia Public Enquries
Role Name Email Phone Street address
Scientific Enquiries Darartu Neme nemedere@gmail.com +251913386656 Dilla, Ethiopia
City Postal code Country Position/Affiliation
Dilla Ethiopia Scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide any information upon request by authorized body Statistical Analysis Plan within 12 months RCT
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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