Prevention of Postspinal Shivering Clinical Trial
Official title:
Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
| Verified date | August 2020 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an
involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients
undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and
systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation
system by inhibiting tonic vasoconstriction, which plays a significant role in temperature
regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below
the block level) to the peripheral tissues. These two effects predispose patients to
hypothermia and shivering. The median incidence of shivering related to regional anesthesia
observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic
acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering
may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid
these intraoperative and postoperative shivering-induced increases in hemodynamic and
metabolic demands is to prevent shivering in the first place. Although magnesium is among
several pharmacological agents used for the treatment of shivering, its effects on prevention
of shivering during central neuraxial blockade have not been evaluated to date. Henceforth,
the aim of this study was to evaluate the effect of magnesiume on shivering during spinal
anesthesia.
Aim:
to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention
of post spinal shivering in adult patients undergoing elective lower limb orthopedic
surgeries.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | June 3, 2020 |
| Est. primary completion date | June 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Age between 20-45 years old - Both genders - ASA I, II Exclusion Criteria: - Patients with hemodynamic instability - cardiopulmonary - renal , liver disease - hypo or hyperthyroidism - cerebrovascular insufficiency - coagulation defects - those with psychiatric disorder - patients receiving vasoactive drugs or beta blockers - BMI > 35 - allergic to study drug - height <160 cm or >190 cm - basal body temperature >38°C or <36°C - those who received blood transfusion or >2000 mL fluid intra-operatively - surgery duration > 3 hours |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | anesthesia department at Cairo University | Cairo | Elmanial |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | incidence of postspinal shivering | the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body | up to 5 months |