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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Fathy Tash, M.D., 202 2685 7539, Fathytash@yahoo.com
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
- Being tested
- Hydrocortisone, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
received 2mg/kg.
DexmedetomidineDrug
received 1 µg/kg
| Study group | Role | What 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.
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.
- First posted4 Sep 2025
- Study start11 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha sadek El Derh, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07154849
- Acronym / sponsor ID
- FMASU MS581 /2024
- Conditions
- Shivering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A:(Hydrocortisone group) | Active comparator | Drug: Hydrocortisone• Group A: : received 2mg/kg. |
| Group B: (Dexmedetomidine group) | Active comparator | Drug: Dexmedetomidine• Group B: : received 1 µg/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisonereceived 2mg/kg. | Drug | Group A:(Hydrocortisone group) |
| Dexmedetomidinereceived 1 µg/kg | Drug | Group B: (Dexmedetomidine group) |
Primary outcome
Number of participants with body respond to decrease in body temperature by shivering
Time frame: 30 minutes
In this study it was targeted to assess the efficacy of hydrocortisone and dexmedetomidine in reducing shivering that occur post operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.