Trials Sponsors Conditions Drugs Pricing

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 SolutionDrug

will receive granisetron 3 mg iv bolus

granisetron group

PethidinDrug

will receive pethidine 25 mg iv bolus

pethidine group

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Ain Shams University

Cairo, Egypt

MeSH Terms

Interventions

GranisetronMeperidine

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Ayman M Kamaly, MD
Ain Shams University
STUDY CHAIR
David S Said, Msc
Ain Shams University
PRINCIPAL INVESTIGATOR

Enrollment

330 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

granisetron group

pethidine group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

granisetron group

pethidine group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations