NCT06612996

Brief Summary

The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_4

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 23, 2024

Last Update Submit

September 23, 2024

Conditions

Lower Extremity Chronic Venous UlcersVaricose Veins LegHernia

Keywords

TramadolMagnesium SulphateShivering

Outcome Measures

Primary Outcomes (1)

  • Shivering score

    Shivering score

    90 minutes postoperatively

Study Arms (3)

Tramadol group

EXPERIMENTAL

Intravenous Tramadol

Drug: Tramadol

Magnesium sulphate group

EXPERIMENTAL

Intravenous Magnesium Sulphate

Drug: Magnesium sulphate

Control group

PLACEBO COMPARATOR

Saline

Other: Saline

Interventions

TramadolDRUG

Intravenous tramadol

Tramadol group
Magnesium sulphateDRUG

Intravenous magnesium sulphate

Magnesium sulphate group
SalineOTHER

Normal saline

Control group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.

You may not qualify if:

  • history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \>38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia

Interventions

TramadolMagnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Central Study Contacts

Warda Demerdash Ali, PhD

CONTACT

088 2148087warda2001@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 25, 2024

Study Start

October 10, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share