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ShiveringPhase 4NCT07154849

Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries

A Phase 4 study testing Hydrocortisone and Dexmedetomidine in people with Shivering, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Shivering
What is being tested?
Hydrocortisone and Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
11 Nov 2024to 20 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

maha SMD elDerh, M.D. contact

+20224190092

mahasadek81@yahoo.com

Egypt1 site, 1 recruiting
  • Ain Shams University

    Cairo

    Fathy Tash, M.D., 202 2685 7539, Fathytash@yahoo.com

    Recruiting

Other trials in Egypt

About this study

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.

Read the detailed description
  • . Type of Study: Randomized controlled clinical trial.
  • Study Settings: Ain Shams University hospitals, Cairo, Egypt.
  • Study Population: patients undergoing abdominal open surgeries with general anesthesia.
  • Inclusion Criteria:
  • ASA I or ASA II patients Scheduled for abdominal surgery under general anaesthesia.
  • Age between18-65 years.
  • Procedure duration ≤ 120 minutes.
  • Exclusion Criteria:
  • 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.
  • Sampling Method: Simple randomization
  • Standard care Standard care for all patients undergoing this study will be done by senior staff expert members of Ain-Shams University Anesthesia department and will be monitored by supervisors.
  • Study Procedures:
  • Preoperative settings:

All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.

  • Intraoperative and postoperative settings:

Patients will be divided into two groups:

  • Group A: (HYDROCORTISONE group): will receive 2mg/kg .
  • Group B: (Dexmedetomidine group): will receive 1 µg/kg . On arrival to the operating room, routine monitors will be applied, including a blood pressure cuff, electrocardiogram, pulse oximeter, and capnogram. core temperature will be measured using temperature probe to determine baseline values. An intravenous ringer infusion will be started. Pre oxygenation will be done with 100% oxygen on 6L\m for 3 minutes. Anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 mic\kg and atracurium 0.5 mg/kg. After endotracheal intubation, anesthesia will be maintained with 1.2-1.5% isoflurane. Mechanical ventilation will be adjusted to maintain end-tidal carbon dioxide tension at 30-35 mmHg Patients will be covered with surgical drapes. Supplemental doses of atracurium will be given every 20 minutes to maintain muscle relaxation during surgery.

Approximately 30 minutes before the anticipated completion of surgery, the study drugs will be given to the two groups.

Ephedrine (10 mg IV bolus) will be given for hypotension (systolic blood pressure < 80 mmHg) and atropine (0.5 mg IV bolus) will be given for bradycardia (HR < 50 BPM).

At the end of surgery, extubation will be done and patients will be transferred to the post-anaesthesia care unit (PACU), for further monitoring.

  • Postoperative settings: Patients will be transferred to the post-anaesthesia care unit (PACU) and will be put under observation for 30 minutes.
  • Measurements: Baseline core temperature (pre-induction) will be taken as the first measurement in the operating room. Heart rate and non-invasive blood pressure readings will be recorded.

Core temperature will be measured directly after endotracheal intubation and every 15 minutes during the operation. Upon transferal of the patient to the post-anesthesia care unit (PACU), core temperature will be measured and shivering will be graded from (0-3) according to the shivering scale validated by Crossley and Mahajan as follows: 0 = no shivering, 1 = mild fasciculation of the face or neck, 2 = visible tremor involving more than one muscle group, 3 = gross muscular activity involving the entire body.

  • Primary outcome: To compare the efficacy of hydrocortisone and dexmedetomidine in reducing shivering post operatively.
  • Secondary outcomes: Measurement of the hemodynamic changes if present.
Conditions
Shivering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07154849
Study groupRoleWhat they receive
Group A:(Hydrocortisone group)Active comparator• Group A: : received 2mg/kg.
Receives: Drug: Hydrocortisone
Group B: (Dexmedetomidine group)Active comparator• Group B: : received 1 µg/kg.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start11 Nov 2024
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion20 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154849
Sponsor's protocol ID
FMASU MS581 /2024
Status last verified
Sep 2024
First submitted
13 Aug 2025
Last updated
4 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydrocortisone and Dexmedetomidine in people with Shivering, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact maha SMD elDerh, M.D. (+20224190092, mahasadek81@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with body respond to decrease in body temperature by shivering (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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