The effect of single intraoperative dose of dexamethasone on the blood glucose concentration in diabetic and non-diabetic patients : A Double blinded randomised control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Blood sugar values
研究概览
简要总结
Double blinded, randomized, controlled study Written informed consent will be taken from willing patients posted for elective surgery under general anesthesia. Pre operative blood sugar values will be documented along with age, gender, body mass index, type of surgery. Double blinding will be ensured by using preloaded 2 ml syringe of dexamethasone of 4 mg/ml dilution (labeled A) and saline (labeled B), prepared by an anesthesia resident unaware of allocation, after the opening of a sealed opaque envelope containing the randomized assignment. Patients will be allocated to one of four groups: non-diabetics receiving saline; non-diabetics receiving dexamethasone; diabetics receiving saline; and diabetics receiving dexamethasone.
The study drug or saline control will be administered at induction of anesthesia. No dextrose containing solution will be administered during the study. In the OT after attaching standard ASA monitors, anesthesia will be induced with propofol iv after premedication with intravenous glycopyrrolate, Midazolam, ondansetron 4mg, fentanyl. Muscle relaxation will be achieved with atracurium 0.5mg/kg and endotracheal intubation done. At the end of surgery patients will be extubated after reversal of neuromuscular blockade. For the diabetic patient intraoperatively blood glucose monitoring will be done as per protocol. All blood glucose levels will be measured using a calibrated glucometer, SD code free (SD Biosensor,Inc.).The blood glucose measurements will be obtained from finger prick capillary blood samples, by anaesthesiology resident blinded to study group The total amount of insulin administered for the treatment of perioperative hyperglycemia will be recorded. Standard treatment care will be given to diabetic patients.
Blood sugar values two hours after dexamethasone /placebo administration as well as FBS and PPBS on POD 1,2 will be taken as primary endpoints. PONV will be assessed using a 4-point verbal descriptive scale which consists of score 0=no PONV, score1 = mild PONV: patient complaints of nausea but refuses antiemetic treatment, score 2 = moderate PONV: patient complaints of nausea and needs antiemetic treatment; score 3= severe PONV.
Patients who experience PONV in the recovery area will be treated with intravenous metoclopramide (10 mg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.ASA I, II 2.Patients undergoing general anesthesia for elective Laparoscopic surgeries.
排除标准
- •Preoperative use of steroids,Peptic Ulcer,Pregnancy,Malignancy,Immunosuppression,Severe Renal Impairment,Pre-operative blood glucose levels greater than 11.1 mmol.l.
结局指标
主要结局
Blood sugar values
时间窗: Two hours after dexamethasone /placebo administration as well as FBS and PPBS on POD 1,2.
次要结局
- Post operative nausea & vomiting(Post operative period 2,8 hour,pod1,2.)
研究者
Nadia Rose
Rajarajeswari medical college and hospital
