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Clinical Trials/CTRI/2024/03/063644
CTRI/2024/03/063644Not yet recruitingPhase 3 4

EFFECT OF A SINGLE INTRAOPERATIVE DOSE OF DEXAMETHASONE ON GLYCEMIC PROFILE IN POST OPERATIVE PATIENTS, UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA: RANDOMISED CONTROLLED TRIAL

Dr SN Medical College Jodhpur1 site in 1 country100 target enrollmentStarted: March 15, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
To compare the changes in the glycemic profile up to 72hours in patients receiving a single dose of dexamethasone in elective laparoscopic surgery

Study Overview

Brief Summary

This study will be conducted in the department of Anaesthesiology, Dr. S. N. MEDICAL COLLEGE and associated group of hospitals on patients posted for laparoscopic surgery . The aim is to study the effect of a single dose of dexamethasone on glycemic profile up to 72hours in postoperative patients undergoing elective laparoscopic surgery under general anaesthesia and also to  compare the incidence of postoperative nausea and vomiting (PONV) and Postoperative pain in term of VAS score.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • The patients of aged 18-70 years with Body Mass Index (BMI) ranging from 18.5 to 24.9 kg/m2, American Society of Anesthesiologists (ASA) physical status I and non-diabetic ASA II status posted for elective laparoscopic surgery will be recruited and studied for 72 hours.

Exclusion Criteria

  • Candidates with preexisting diabetes mellitus (FBS more than 126 mg/dl, postprandial blood sugar (PPBS) more than 200 mg/dl, HbA1c more than 6.5), Chronic steroid therapy (taking steroid more than 10mg, for more than 10 days within last 10 months), History of allergy to dexamethasone, Pregnancy, History of peptic ulcer disease, Malignancy, Duration of anaesthesia more than 2 hours, Patients who have history of any vomiting, Retching, or nausea in the 24 hours preceding the administration of anaesthesia.

Outcomes

Primary Outcomes

To compare the changes in the glycemic profile up to 72hours in patients receiving a single dose of dexamethasone in elective laparoscopic surgery

Time Frame: To compare the changes in the glycemic profile up to 72hours in patients receiving a single dose of dexamethasone in elective laparoscopic surgery

Secondary Outcomes

  • To compare the incidence of postoperative nausea and vomiting (PONV)(And Postoperative pain in term of VAS score.)

Investigators

Sponsor
Dr SN Medical College Jodhpur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

jyoti

Dr SN Medical College, Jodhpur , Rajasthan

Study Sites (1)

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