Intraoperative opioid versus non-opioid induced delay in perioperative gastric emptying: A comparative randomised double blind controlled study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- To detect opioid-induced delay in gastric emptying in the perioperative period
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To detect opioid-induced delay in gastric emptying in the perioperative period
Time Frame: Gastric residual volume will be measured before induction of anaesthesia, immediately after surgery, 2 hours postoperative, 6 hours postoperative
Secondary Outcomes
- 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.)