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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07154849
Enrollment
70
Registered
2025-09-04
Start date
2024-11-11
Completion date
2025-12-20
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shivering

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.

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.

Interventions

DRUGHydrocortisone

received 2mg/kg.

DRUGDexmedetomidine

received 1 µg/kg

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

any patient undergoing abdominal surgery ASAI or II. \-

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with body respond to decrease in body temperature by shivering30 minutesIn this study it was targeted to assess the efficacy of hydrocortisone and dexmedetomidine in reducing shivering that occur post operatively.

Countries

Egypt

Contacts

Primary Contactmaha SMD elDerh, M.D.
mahasadek81@yahoo.com+20224190092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026