Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexame… (NCT05284409) | Clinical Trial Compass
CompletedPhase 4
Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexamethasone vs Pethidine Regarding the Incidence of Shivering Induced by Single Shot Spinal Anesthesia in the Orthopedic Surgeries of the Lower Limbs
Egypt130 participantsStarted 2022-07-01
Plain-language summary
Single Shot Spinal anesthesia (SSSA) is associated with considerable perioperative shivering and can be challenging to treat. Some pharmacologic agents like N-methyl d-aspartate receptor antagonists, magnesium sulfate and opioid analgesics have been used for restriction of post-spinal anesthesia shivering. Besides that shivering is poorly understood, the gold standard for the treatment and prevention has not been defined yet.
This study is to determine the effect of prophylactic intravenous administration of acetaminophen versus dexamethasone versus pethidine in controlling shivering induced by spinal anesthesia
Who can participate
Age range
20 Years – 55 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:
* American Society of Anesthesiologists physical status (ASA) I or II.
* Both sexes.
* Age ranging from 20 to 55 years old.
* Body weight ranging from 60 to 100 kilograms.
* Receiving Single Shot Spinal anesthesia.
* Scheduled for orthopedic surgeries of the lower limb.
Exclusion Criteria:
* Patient's refusal.
* Allergy to local anesthetics or any of the studied drugs.
* Patients with significant cognitive dysfunction.
* Duration of surgery more than 120 min.
* Patients with hypo- or hyperthyroidism.
* An initial body temperature \>38.0 or \<36.0 degree Celsius.
* Receiving vasodilators, or medications likely to alter thermoregulation.
* Pregnancy.
* Sensory blockade level reaching T4 or higher.
* Obesity (BMI \> 35 kg/m2).
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
The incidence of shivering
Timeframe: During procedure to up to one hour at the post-anesthesia care unit (PACU)