A clinical trial to see if Dexmedetomidine (a sleep drug) helps in blood sugar control during laparoscopic surgeries in diabetic patients.

Not yet recruiting

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary: This study is a randomized, double blinded, placebo controlled trial assessing the efficacy of Intravenous Dexmedetomidine on Intraoperative Insulin requirement among adults with Diabetes Mellitus undergoing Laparoscopic Surgery under General Anaesthesia and will be conducted in JIPMER, Puducherry as a part of post-graduate dissertation. The primary outcome measure will be the number/percentage of patients requiring intraoperative insulin. The secondary outcomes will be intraoperative hemodynamic parameters such as heart rate, blood pressure, mean arterial pressure; and the levels of cortisol and IL-6 measured before induction of anaesthesia and then just before deflation of pneumoperitoneum. The proposed hypothesis is that Intravenous Dexmedetomidine is effective in reducing the requirement of intraoperative insulin among diabetic adults undergoing laparoscopic surgeries.

Recruitment & Eligibility

Inclusion Criteria

1. Adults aged 18 to 70 years with diabetes mellitus with ASA PS 2 and 3 scheduled to undergo elective laparoscopic surgery under general anaesthesia.
1. Duration of pneumoperitoneum, minimum 2 hours and maximum 6 hours.
1. Preoperative baseline blood sugar value, less than 180 mg/dL.

Exclusion Criteria

Patients with known allergy to dexmedetomidine 2) Patients with severe cardiovascular disease or pulmonary disease, end-stage renal disease or decompensated liver disease.

Primary Outcome Measures

Name	Time	Method
The number/percentage of patients requiring intraoperative insulin	No specific time points for this outcome measure. Capillary blood sugar values will be measured at baseline, and then every hour after starting dexmedetomidine infusion till the end of surgery. Insulin infusion will be started if blood sugar value is found to be higher than 180mg/dL intraoperatively.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters - Heart rate, blood pressure, mean arterial pressure	every 5 minutes for 60 minutes after initiating drug infusion, and then every 15 minutes till the end of surgery and extubation
Serum cortisol and IL-6 levels	before induction of anaesthesia and just before deflation of pneumoperitoneum
Incidence of hypoglycemia

Locations (1): Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳Pondicherry, PONDICHERRY, India
Dr Surya S
Principal investigator
7339407504
nithinsurya44@gmail.com