Shivering Clinical Trial
Official title:
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
Verified date | September 2022 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 108 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of shivering | The incidence of shivering induced by single shot spinal anesthesia after the prophylactic administration of the study medications.
When shivering occurs, it will be graded using Bedside Shivering Assessment Scale (BSAS): 0 - None: No Shivering, 1 - Mild: Shivering localized to neck/thorax, maybe seen only as artifact on ECG or felt by palpation 2 - Moderate: Intermittent involvement of the upper extremities +/- thorax 3 -Severe: Generalized shivering or sustained upper / lower extremity shivering. In all of the groups, the degree of shivering will be assessed at the time of its onset either intra or postoperatively, and throughout the duration of one hour at the post-anesthesia care unit (PACU). Grade 3 or 4 of shivering score will be regarded as failure of prophylaxis, and a rescue dose of 0.2 mg/kg Pethidine IV will be administered and the total dose will be recorded. |
During procedure to up to one hour at the post-anesthesia care unit (PACU) | |
Secondary | The need to administer pethidine | In all of the groups, the degree of shivering will be assessed at the time of its onset either intra or postoperatively, and throughout the duration of one hour at the post-anesthesia care unit (PACU). Grade 3 or 4 of shivering score will be regarded as failure of prophylaxis, and a rescue dose of 0.2 mg/kg Pethidine IV will be administered. | The time of administration of pethidine | |
Secondary | the total dose of Pethidine given | In all of the groups, the degree of shivering will be assessed at the time of its onset either intra or postoperatively, and throughout the duration of one hour at the post-anesthesia care unit (PACU). Grade 3 or 4 of shivering score will be regarded as failure of prophylaxis, and a rescue dose of 0.2 mg/kg Pethidine IV will be administered and the total dose will be recorded. | The time of administration of pethidine | |
Secondary | The patient's satisfaction | Patient's satisfaction will be assessed by asking the patient to answer the question, "How would you rate your experience after the operation?" using a 7-point Likert verbal rating scale, and acceptable satisfaction score of the patient will range from 5 to 7 (1 - Extremely dissatisfied, 2 - Dissatisfied, 3 - Somewhat dissatisfied, 4 - Undecided, 5 - Somewhat satisfied, 6 - Satisfied, 7 - Extremely satisfied). | up to one hour postoperative | |
Secondary | The level of sedation | The level of sedation will be assessed according to a five-point range: [1] alert and oriented, [2] somnolent, [3] closed eyes, arousable on a verbal order, [4] closed eyes, arousable to physical stimuli and [5] closed eyes and patient unarousable to physical stimuli. | within 5 minutes after the administration of sedative | |
Secondary | Pruritus | Severity of pruritus. Pruritus will be assessed by a four-point ordinal scale where zero points to no itching, one points to mild itching, two points to moderate itching, treatment not requested, three points to severe itching, treatment requested. | during procedure |
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