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A clinical trial to study the effect of dexamethasone in patients undergoing middle ear surgery

GLYCEMIC PROFILE AFTER A SINGLE DOSE OF DEXAMETHASONE IN PATIENTS UNDERGOING MIDDLE EAR SURGERY-A DOUBLE BLIND RANDOMISED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017570
Enrollment
150
Registered
2019-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R739- Hyperglycemia, unspecified

Interventions

Intervention1: Dexamethasone: 0.10 - 0.15 mg/kg single dose during induction of anesthesia Control Intervention1: Normal saline: 2ml at induction of anesthesia

Sponsors

Jubilee M ission Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Glycemic profile for 72 hrs after a single dose of dexamethasone in patients undergoing middle ear surgeryTimepoint: pre-op and Post op( 2 hours after dexamethasone administration):- point-of-care (finger-stick) glucose determinations ô??¾ POD(Post operative day) 1, 2, 3:- Fasting and postprandial point-of-care (finger-stick) glucose determinations—

Secondary

MeasureTime frame
1.Postoperative Nausea and Vomiting 2.Pain 3.Fever 4.Post-operative dizziness 5.Insulin â?? dose and frequency of administration 6.Hospital length of stay 7.Surgical site infectionTimepoint: 1-Incidence of PONV will be noted on POD 1,2,3 2:- Pain will be noted on POD 1,2,3 3-Fever will be noted on POD 1,2,3 4-Dizziness will be noted on POD(Post operative day)1, 2, 3 5-At the time of discharge-dose and frequency of insulin administrated 6. Hospital length of stay- noted at the time of discharge 7--Surgical site infection will be assessed any point during the hospital stay—

Countries

India

Contacts

Public ContactDr Vigil Peter

Jubilee Mission Medical College and Research Institute Thrissur

drpeteralapatt@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026