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

NCT06513806 | Completed Phase 4

• 1 other identifier: FMASU MS84/2024
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain assessment

  12 hours postoperative

• nausea, vomiting

  12 hours postoperative

Study Arms (2)

granisetron group

ACTIVE COMPARATOR

will receive granisetron 3 mg iv bolus

Drug: Granisetron 1 Mg/mL Intravenous Solution

pethidine group

ACTIVE COMPARATOR

will receive pethidine 25 mg iv bolus

Drug: Pethidin

Interventions

Granisetron 1 Mg/mL Intravenous Solution DRUG

will receive granisetron 3 mg iv bolus

granisetron group

Pethidin DRUG

will receive pethidine 25 mg iv bolus

pethidine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Granisetron; Meperidine

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isonipecotic Acids; Acids, Heterocyclic; Piperidines

Study Officials

• Ayman M Kamaly, MD

  Ain Shams University

  STUDY CHAIR

• David S Said, Msc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 28, 2024
• Last Updated: October 2, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)