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

NCT ID: NCT06513806

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-09-28

Brief Summary

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

Detailed 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

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

granisetron group

will receive granisetron 3 mg iv bolus

Group Type: ACTIVE_COMPARATOR

Granisetron 1 Mg/mL Intravenous Solution

Intervention Type: DRUG

will receive granisetron 3 mg iv bolus

pethidine group

will receive pethidine 25 mg iv bolus

Group Type: ACTIVE_COMPARATOR

Pethidin

Intervention Type: DRUG

will receive pethidine 25 mg iv bolus

Interventions

Granisetron 1 Mg/mL Intravenous Solution

will receive granisetron 3 mg iv bolus

Intervention Type: DRUG

Pethidin

will receive pethidine 25 mg iv bolus

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdou

associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman M Kamaly, MD

Role: STUDY_CHAIR

Ain Shams University

David S Said, Msc

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS84/2024

Identifier Type: -

Identifier Source: org_study_id