跳至主要内容
临床试验/CTRI/2025/02/081250
CTRI/2025/02/081250尚未招募不适用

Effect of pre surgery carbohydrate drink on the incidence of post spinal hypotension in elderly patients undergoing transurethral resection of prostate: A randomised control trial

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Comparison of incidence of postspinal hypotension in patients undergoing TURP with pre surgery carbohydrate loading and conventional fasting guidelines.

研究概览

简要总结

Preoperative fasting guidelines are a necessary component of surgical preparation of the patient. The American Society of Anesthesiologists (ASA) have conventionally recommended a period of fasting of 6 hours for light meals and 2 hours for clear liquids for adults undergoing elective surgeries. Adequate fasting periods are required to prevent adverse intra operative complications like pulmonary aspiration of gastric contents. In recent times, adaptability to the said fasting periods have been proposed with an aim to reduce prolonged fasting. Long hours of fasting preoperatively can lead to dehydration, patient discomfort and increased catabolic response to surgery. A modular update of The Practice guidelines for preoperative fasting periods were introduced by the ASA in 2017 that focused on reducing unnecessary prolonged fasting periods along with the use of pre surgery carbohydrate drinks.

Additionally, post spinal induction hemodynamic instability intraoperatively has been known to occur significantly more in the elderly age group. The incidence of spinal induced hypotension increases up till 75% in age group over 5o years of age as opposed to 36% incidence in younger age groups.

Therefore, with the use of of pre-surgical carbohydrate loading as per the Modular ASA guidelines, we aim to evaluate the incidence of and measure intraoperative hypotension occurring in elderly age groups consuming pre surgery carbohydrate loading among patients posted for elective Transurethral Resection of Prostate (TURP) under spinal anesthesia and contrast this with another matched cohort following conventional preoperative fasting advice. It will be a Randomized controlled trial, single blinded study. In conjecture to this we aim to hypothesise the mean duration of preoperative fasting that the latter group of patients follow as per conventional nil per oral fasting guidelines in our institute.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • Adult males (60-90 years), ASA 1, 2 undergoing elective Transurethral Resection of Prostate under Spinal Anaesthesia.

排除标准

  • Patients belonging to ASA 3,4
  • Patients with Diabetes Mellitus
  • Patients with Hypertension and on treatment with diuretics
  • Patients with Gastric motility disorders like GERD
  • Patients with Opioid use
  • Patients with known cardiac disease.

结局指标

主要结局

Comparison of incidence of postspinal hypotension in patients undergoing TURP with pre surgery carbohydrate loading and conventional fasting guidelines.

时间窗: Within 20 minutes of Spinal anaesthesia

次要结局

  • To compare postoperative nausea & vomiting
  • To compare perioperative blood glucose levels with pre surgery carbohydrate loading & conventional fasting guidelines.
  • To compare patient discomfort due to hunger and/or thirst in patients undergoing TURP under spinal anesthesia with pre surgery carbohydrate loading & conventional fasting guidelines.
  • To evaluate the mean fasting duration of patients advised to follow conventional fasting guidelines.

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Swati Chhabra

All India Institute of Medical Sciences Jodhpur

研究点 (1)

Loading locations...

相似试验