NCT06031090

Brief Summary

Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

August 27, 2023

Last Update Submit

September 8, 2023

Conditions

Post Spinal Anesthesia Shivering

Outcome Measures

Primary Outcomes (1)

  • Incidence of Shivering

    • Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body

    Procedure (through out the period of spinal anesthesia)

Secondary Outcomes (4)

  • core body temperature

    Procedure (preoperative as base and through out the period of spinal anesthesia)

  • Maternal Heart rate

    Procedure (preoperative as base and through out the period of spinal anesthesia)

  • baby APGAR score

    1 minutes and 5 minutes post natal

  • maternal blood presure

    Procedure (preoperative as base and through out the period of spinal anesthesia)

Other Outcomes (1)

  • maternal oxygen saturation

    Procedure (preoperative as base and through out the period of spinal anesthesia)

Study Arms (3)

Group Cl (clonidine group)

ACTIVE COMPARATOR

will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Drug: Clonidine Injection

Group G (granisetron group)

ACTIVE COMPARATOR

will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.

Drug: Granisetron Injection

Group C (control group)

PLACEBO COMPARATOR

will be given intravenous10ml normal saline 20 minutes before spinal anesthesia

Drug: Normal Saline 10 mL Injection

Interventions

Clonidine InjectionDRUG

intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Group Cl (clonidine group)
Granisetron InjectionDRUG

intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.

Group G (granisetron group)
Normal Saline 10 mL InjectionDRUG

intravenous 10 ml normal saline 20 minutes before spinal anesthesia

Group C (control group)

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparturients undergoing cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba M Fathi

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Interventions

ClonidineGranisetronSaline SolutionInjections

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Heba M Fathi, M.D

CONTACT

00201000143938heba_elgendi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
triple blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor

Study Record Dates

First Submitted

August 27, 2023

First Posted

September 11, 2023

Study Start

March 5, 2023

Primary Completion

October 5, 2023

Study Completion

October 30, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

EG(1)