The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Adminis… (NCT06769737) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations
Saudi Arabia75 participantsStarted 2025-03-01
Plain-language summary
This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients in adult age group more than 18 years old
* ASA classification I, II, and III.
* Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
* No history of Obstructive sleep apnea
Exclusion Criteria:
* Patient below 18 years old of both genders.
* ASA classification of IV and more.
* Patients with a height of less than 150 cm.
* Patients on alpha-two antagonist ACE inhibitors and CCB.
* Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam
* Patient who can't tolerate fluid challenge. Example: ESRD, HF…etc.
* Any contraindication for neuraxial procedure. Examples: coagulopathy, severe AS, sepsis…etc.
* Psychiatric patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regression time of Bromage score from 3 to 0
Timeframe: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.