A clinical trial to study the effect of dexamethasone in patients undergoing middle ear surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: R739- Hyperglycemia, unspecified
- Registration Number
- CTRI/2019/02/017570
- Lead Sponsor
- Jubilee M ission Medical College and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Patients requiring mastoidectomy and tympanoplasty for Chronic suppurative otitis
media
-ASA(PS),American Society of Anesthesiologists(Physical status) class 1 or 2
-Euthyroid
-Elective surgery
Exclusion Criteria
-Known diabetic patients(fasting blood sugar >126, postprandial blood sugar > 200,
HbA1c > 6.5)
-Chronic steroid therapy
-History of allergy to dexamethasone
-ASA(PS)American Society of Anesthesiologists(Physical status) 3,4
-Pregnancy
-Duration of surgery more than 4 hrs
-h/o gastric or duodenal ulcer
-Significant comorbidities-hepatorenaldysfunction, malignancy, immunosuppression.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic profile for 72 hrs after a single dose of dexamethasone in patients <br/ ><br>undergoing middle ear surgeryTimepoint: pre-op and Post op( 2 hours after dexamethasone administration):- <br/ ><br>point-of-care (finger-stick) glucose determinations <br/ ><br> <br/ ><br>ô??¾ POD(Post operative day) 1, 2, 3:- <br/ ><br>Fasting and postprandial point-of-care (finger-stick) glucose determinations
- Secondary Outcome Measures
Name Time Method 1.Postoperative Nausea and Vomiting <br/ ><br>2.Pain <br/ ><br>3.Fever <br/ ><br>4.Post-operative dizziness <br/ ><br>5.Insulin â?? dose and frequency of administration <br/ ><br>6.Hospital length of stay <br/ ><br>7.Surgical site infectionTimepoint: 1-Incidence of PONV will be noted on POD 1,2,3 <br/ ><br>2:- Pain will be noted on POD 1,2,3 <br/ ><br>3-Fever will be noted on POD 1,2,3 <br/ ><br>4-Dizziness will be noted on POD(Post operative day)1, 2, 3 <br/ ><br>5-At the time of discharge-dose and frequency of insulin administrated <br/ ><br>6. Hospital length of stay- noted at the time of discharge <br/ ><br>7--Surgical site infection will be assessed any point during the <br/ ><br>hospital stay