Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia; Adverse Effect, Spinal and Epidural

Treatments: Drug: Pethidin; Drug: Granisetron 1 Mg/mL Intravenous Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06513806

FMASU MS84/2024

Details and patient eligibility

About

Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections

Full description

Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.

Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.

Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)

If shivering occurs the degree of Shivering will be classified as:

• 0: No shivering
• 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
• 2: Visible tremor involving more than one muscle group
• 3: Gross muscular activity involving the entire body

Enrollment: 330 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.
• Age 18 - 45

Exclusion Criteria

• Inability to provide informed consent.
• Previous allergies or sensitivities to granisetron or pethidine.
• Current use of medications that may interact with granisetron or pethidine.
• Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.
• Patients who are too short (<140 cm) or too tall (>190 cm)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups

granisetron group

Active Comparator group

Description:

will receive granisetron 3 mg iv bolus

Treatment:

Drug: Granisetron 1 Mg/mL Intravenous Solution

pethidine group

Active Comparator group

Description:

will receive pethidine 25 mg iv bolus

Treatment:

Drug: Pethidin