A Randomized,controlled,Study for effect of single dose of intraoperative dexamethasone on variation in blood glucose level in pediatric hypospadias surgery in department of anesthesia,SMS Medical College,Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate & compare the difference, in change in blood glucose levels at various time points in dexamethasone v/s control group.
研究概览
简要总结
After obtaining Institutional Ethics Committee approval and written informed consent, 72 patients fulfilling inclusion criteria and undergoing elective surgery for hypospadias will be included.
Patient satisfying inclusion criteria and Pre anesthetic check up(PAC) fitness will be selected and taken into OT. Patient will be identified and informed written consent will be checked. Randomization will be done using opaque sealed envelope method. All monitors will be attached and baseline vitals will be recorded. Baseline blood sugar will be recorded and Glycopyrrolate(5ug/kg) Midazolam (0.05mg/kg) and Fentanyl (2ug/kg) will be administered to the patient via already secured I.V. line. Induction of the patient will be done using I.V. propofol 2mg/kg and I.V. atracurium(0.5mg/kg) to facilitate endotracheal intubation to secure airway in every patient. Now, Group A will be administered single dose of dexamethasone(0.15mg/kg) and Group B will be given saline through prefilled 5ml syringes that the anesthesiologist administering will not know about because of the blinding process. Post that, the patient will be put to left lateral position and under all aspetic preacautions ,painting and draping will be done at and around the caudal block site, and caudal block will be administered to the patient using ropivacaine (0.2%) in dose 0.5 ml/kg. Blood glucose will be recorded 2 hours after administering dexamethasone. Maintainence of anesthesia will be done by oxygen, nitrous oxide and sevoflurane. At the end of surgery, all the anesthetic agents will be discontinued and patient will be taken on 100% oxygen. Reversal of neuromuscular block will be done by I.V. neostigmine(0.05 mg/kg) and I.V. Glycopyrrolate (0.01mg/kg). On regain of adequate muscle power ,extubation will be done and the patient will be shifted to recovery room.
Post surgery ,patient will be assessed at regular time points for post-operative pain (using FLACC score), nausea,vomiting,fever,surgical site infection. Fasting blood sugar and post-prandial blood sugar will be recorded upto 72 hours of post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- Male
入选标准
- •Children (3-6 years) undergoing hypospadias surgery.
- •Parents/caretaker willing to consent for participation.
- •Patients belonging to American society of Anesthesiologists (ASA) grade I and II.
排除标准
- •Patients with Diabetes Mellitus.
- •Patients on immunosuppressive /steroid therapy.
- •Patients with known allergy to dexamethasone.
- •Patients with hepatorenal dysfunction.
结局指标
主要结局
To evaluate & compare the difference, in change in blood glucose levels at various time points in dexamethasone v/s control group.
时间窗: Baseline(pre_operative), | 2 hours after administration of dexamethasone/saline, | Fasting blood sugar and Post prandial blood sugar on : | Post_operative day: 1,2 and 3.
次要结局
- 1. To assess & compare the difference in mean no of doses & total doses of rescue analgesic needed in post-operative period upto 12 hours in both the groups.(2. To assess & compare the difference in proportion of patients who experienced post-operative nausea, vomiting upto 12 hours in both the groups.)