NCT07154849

Brief Summary

The aim and purpose of this study is to compare the efficacy of intravenous hydrocortisone and intravenous dexmedetomidine for prevention and treatment of postoperative shivering after general anesthesia for abdominal surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

August 13, 2025

Last Update Submit

September 3, 2025

Conditions

Shivering

Outcome Measures

Primary Outcomes (1)

  • Number of participants with body respond to decrease in body temperature by shivering

    In this study it was targeted to assess the efficacy of hydrocortisone and dexmedetomidine in reducing shivering that occur post operatively.

    30 minutes

Study Arms (2)

Group A:(Hydrocortisone group)

ACTIVE COMPARATOR

• Group A: : received 2mg/kg.

Drug: Hydrocortisone

Group B: (Dexmedetomidine group)

ACTIVE COMPARATOR

• Group B: : received 1 µg/kg.

Drug: Dexmedetomidine

Interventions

HydrocortisoneDRUG

received 2mg/kg.

Group A:(Hydrocortisone group)
DexmedetomidineDRUG

received 1 µg/kg

Group B: (Dexmedetomidine group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with known neurologic and psychiatric illness.
  • Uncontrolled diabetic patients.
  • Patients on long term steroid therapy.
  • Allergy to any of the drugs used in the study.
  • Pregnancy and lactation.
  • Hypo or hyperthyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

HydrocortisoneDexmedetomidine

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

maha SMD elDerh, M.D.

CONTACT

+20224190092mahasadek81@yahoo.com

Study Design

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

Study Record Dates

First Submitted

August 13, 2025

First Posted

September 4, 2025

Study Start

November 11, 2024

Primary Completion

November 1, 2025

Study Completion

December 20, 2025

Last Updated

September 4, 2025

Record last verified: 2024-09

Locations

EG(1)