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 range20 Years – 55 Years

SexALL

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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).

What they're measuring

The incidence of shivering

Timeframe: During procedure to up to one hour at the post-anesthesia care unit (PACU)

Trial details

NCT IDNCT05284409

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-20