Actively Recruiting
Comparative Study Between Intravenous Hydrocortisone and Dexmedetomidine for Preventing Postoperative Shivering After General Anaesthesia in Abdominal Surgeries
Led by Ain Shams University · Updated on 2025-09-04
70
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two intravenous drugs, hydrocortisone and dexmedetomidine, in preventing and treating shivering after general anesthesia in patients undergoing abdominal surgeries. This is a randomized controlled clinical trial conducted at Ain Shams University hospitals, focused on adult patients aged 18 to 65 years who are undergoing abdominal open surgeries lasting up to 120 minutes. The study aims to compare these drugs' ability to reduce postoperative shivering and monitor hemodynamic changes. Participants are randomly assigned to one of two groups: Group A receives hydrocortisone at a dose of 2 mg/kg, and Group B receives dexmedetomidine at 1 microgram/kg. Both drugs are administered intravenously about 30 minutes before the anticipated end of surgery. Standard anesthesia protocols, including induction and maintenance, are followed, with monitoring of vital signs and core temperature throughout the procedure. After surgery, patients are extubated and transferred to the post-anesthesia care unit for observation. During the study, participants undergo regular monitoring of core temperature and vital signs at specific intervals. Shivering is assessed using a validated scale from 0 (no shivering) to 3 (severe whole-body shivering) during the 30 minutes after surgery while in the recovery area. The primary outcome is the number of patients who experience shivering in response to decreased body temperature. Secondary outcomes include observing any changes in heart rate and blood pressure. The total participation includes preoperative assessment, intraoperative treatment, and 30 minutes of postoperative monitoring.
CONDITIONS
Brief Title
Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years
- Scheduled for abdominal surgery under general anesthesia
- ASA physical status I or II
- Surgery duration less than or equal to 120 minutes
You will not qualify if you...
- Patients with known neurologic or psychiatric illness
- Uncontrolled diabetes
- Patients on long-term steroid therapy
- Allergy to hydrocortisone, dexmedetomidine, or related drugs
- Pregnant or breastfeeding women
- Patients with hypo- or hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before surgery
Duration - Up to 2 hours (duration of surgery)
Participants receive intravenous hydrocortisone or dexmedetomidine during surgery to prevent postoperative shivering.
1 intraoperative treatment visit
Duration - 30 minutes
Participants are monitored in the post-anesthesia care unit for 30 minutes to assess shivering and vital signs.
1 post-operative observation visit
Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Egypt
Actively Recruiting
Research Team
M
maha SMD elDerh, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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