跳至主要内容
临床试验/CTRI/2023/11/059949
CTRI/2023/11/059949尚未招募4 期

Intraoperative opioid versus non-opioid induced delay in perioperative gastric emptying: A comparative randomised double blind controlled study

Dr Deekshanth Ramakrishnan1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年11月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
93
试验地点
1
主要终点
To detect opioid-induced delay in gastric emptying in the perioperative period

研究概览

简要总结

Analgesics are widely prescribed for acute and chronic pain. Opium is one of the oldest herbal

medicines currently used as an analgesic, sedative and antidiarrhoeal. The effects of opium are

principally mediated by the μ-, κ- and δ-opioid receptors. Common adverse effects of opioid

administration include sedation, dizziness, nausea, vomiting, delayed gastric emptying,

constipation, dependency and tolerance, and respiratory depression.

Most of their effects on gastrointestinal motility and secretion result from suppression of neural

activity. Inhibition of gastric emptying, increase in sphincter tone, changes in motor patterns, and

blockage of peristalsis result from opioid use. Sedation and general anaesthesia depress or

impede the physiological mechanisms that protect against aspiration (the tone of the lower

oesophageal sphincter and upper airway reflexes).

Although the detrimental effects of opioids on the lower gastrointestinal tract are well known,

the opioid health crisis has certainly brought this to the forefront of gastroenterology with recent

data regarding their impact on esophageal and gastroduodenal motility. Aspiration of gastric

contents is a rare but nevertheless important cause of anaesthetic mortality and morbidity. It is

recognised that opioids can delay gastric emptying and the use of these drugs may increase the

risk of peri-operative aspiration of gastric contents. The delay in gastric emptying may also

reduce the effectiveness of oral analgesics given postoperatively

.

Opiod-free anaesthesia is now a new favourite of anaesthesiologists in journals and in

conferences as a topic of lecture, symposium and panel discussion. However, assessment of

perioperative gastric contents relies almost exclusively on clinical history that may not be

reliable. Older studies have done assessment of perioperative gastric volume by other techniques

such as acetaminophen absorption test, electrical bioimpedance technique, scintigraphy, etc

.

Nowadays, there is a growing interest in the use of bedside ultrasonography to assess gastric

contents and volume. The ISA national preoperative guidelines weakly recommend gastric

ultrasound as a bedside tool for assessing the quality and quantity of gastric contents in the

preoperative period

. The current study will evaluate the intraoperative opioid versus non-

opioid induced delay in perioperative gastric emptying using gastric ultrasound as a bedside tool.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients belonging to ASA physical status I and II 2)Age 18-60 years, belonging to either gender 3)Patients giving informed written and valid consent 4)Patients undergoing upper/lower ureteric and urethral procedures under spinal anaesthesia.

排除标准

  • •Patients with diabetes mellitus, chronic renal failure 2)Pregnant females 3)Patients on any drugs causing a delay in gastric emptying like aluminum hydroxide, antacids, calcium channel blockers, diphenhydramine, L-Dopa, lithium and tricyclic antidepressants(TCAs) •Patients on pantoprazole and metaclopramide •Patients having hypersensitivity to any of the study drugs •Patients with prior history of gastrointestinal disease and gastrointestinal reflux disease.

结局指标

主要结局

To detect opioid-induced delay in gastric emptying in the perioperative period

时间窗: Gastric residual volume will be measured before induction of anaesthesia, immediately after surgery, 2 hours postoperative, 6 hours postoperative

次要结局

  • 1)To find the efficacy of gastric ultrasound as a bedside tool for assessing the quality & quantity of gastric contents in the peri-operative period.(2)To assess the delay in gastric emptying produced by ketamine.)

研究者

发起方
Dr Deekshanth Ramakrishnan
申办方类型
Other [Self ]

研究点 (1)

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