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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
• Intervention / Treatment: Drug: Granisetron 1 Mg/mL Intravenous Solution; Drug: Pethidin

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

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: granisetron group; will receive granisetron 3 mg iv bolus	Drug: Granisetron 1 Mg/mL Intravenous Solution; will receive granisetron 3 mg iv bolus
Active Comparator: pethidine group; will receive pethidine 25 mg iv bolus	Drug: Pethidin; will receive pethidine 25 mg iv bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treating post spinal shivering	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 assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine	perioperatively/periprocedurally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment	pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain	12 hours postoperative
nausea, vomiting	incidence of postoperative complications: nausea, vomiting	12 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Ayman M Kamaly, MD, Ain Shams University; Principal Investigator: David S Said, Msc, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): September 28, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Piperidines; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Indazoles; Pyrazoles; Acids, Heterocyclic; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Isonipecotic Acids; Meperidine; Granisetron
• Other Study ID Numbers: FMASU MS84/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No