Post-operative Nausea and Vomiting Clinical Trial
Official title:
Effect of Adding Azithromycin to Dexamethasone in Preventing Post-operative Nausea and Vomiting in Caesarean Section Under Spinal Anesthesia With Spinal Opiate.
Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.
There are many well-established risk factors for Postoperative nausea and vomiting which are
classified in two classes:
A) Patient related risk factors:
1. Female gender is consistently the strongest risk factor for postoperative nausea and
vomiting, female patient are three times more likely than men to suffer from
postoperative nausea and vomiting.
2. For adult patient, age is a statistically, though not clinically, relevant risk factor,
with the incidence of postoperative nausea and vomiting decreasing as patients age. For
pediatric patients, however, age increases the risk of post-operative vomiting , such
that children older than 3 years have been shown to have an increased risk of
post-operative vomiting compared with children younger than 3 years.
3. Obesity is a strong risk factor for postoperative nausea and vomiting : patients with
body mass index more than 30 have the double risk of postoperative nausea and vomiting.
4. Non-smoking status roughly doubles the patient's risk of postoperative nausea and
vomiting. The specific mechanism underlying smoking's protective effect is unknown, but
one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in
cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of
emetogenic volatile anesthetics.
5. History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer
increases the risk for postoperative nausea and vomiting.
6. History of motion sickness, Meniere's disease or previous postoperative nausea and
vomiting indicates a general susceptibility to postoperative nausea and vomiting.
B) Anesthesia related risk factors:
1. The use of volatile anesthetics is associated with a two-fold increase in the risk of
postoperative nausea and vomiting , with risk increasing in a dose dependent manner.
2. Intraoperative and postoperative opioid use increases the risk of postoperative nausea
and vomiting in a dose dependent manner by the mechanism of reducing muscle tone and
peristaltic activity, thereby delaying gastric emptying, inducing distention, and
triggering the vomiting reflex.
3. The duration of anesthesia can help predict the patient's risk of postoperative nausea
and vomiting, since the duration of anesthesia describes the patient's exposure to
emetogenic stimuli like volatile anesthetics and intraoperative opioids.
There are two lines of anti-emetic drugs used to treat postoperative nausea and vomiting :
The first line is classified into three classes: serotonin antagonists (e.g. ondansetron),
corticosteroids (e.g. dexamethasone), and dopamine antagonists (e.g. droperidol) have similar
efficacy against postoperative nausea and vomiting , with a relative risk reduction of ~25%.
Moreover, they act independently and when used in combination, have additive effects.
Dexamethasone can be effective in preventing postoperative nausea and vomiting in adults and
children. Compared with other operative medications, dexamethasone has equal or even better
efficacy in reducing the incidence of Postoperative nausea and vomiting and has the
advantages of low cost and longer effectiveness as well. The mechanism of the antiemetic
action of dexamethasone is still not clearly known. Glucocorticoids receptors are found in
nucleus of the solitary tract, the raphe nucleus and the area postrema and all are associated
with regulating nausea and vomiting. Dexamethasone may affect postoperative nausea and
vomiting by modulating neurotransmission or receptor density in these nuclei. Clinically,
dexamethasone as a preventive drug against postoperative nausea and vomiting has not caused
fatal outcome; therefore, it is generally considered to be an effective and safe anti-emetic.
Nevertheless, its use in this regard may lead to adverse effects, principally postoperative
hyperglycemia and infection.
The second line is characterized by less favorable side effect profiles or limited evidence
of efficacy: Metoclopramide is a widely used D2 antagonist. Contrary to popular belief, the
10 mg dose has no effect on post-operative nausea and vomiting, but 25-50 mg has similar
efficacy compared with other anti-emetics. Metoclopramide use has been associated with
extrapyramidal and sedative side-effects. Dimenhydrinate is an antihistamine like
promethazine and cyclizine. There are few randomized controlled trials investigating its use
for postoperative nausea and vomiting , and the drug is associated with a significant rate of
side-effects like sedation, dry mouth, visual disturbance, and urinary retention.
Azithromycin , one of macrolides, was introduced in the 1950s and after years of clinical
experience it still remains a commonly relied upon antibiotic but the function of
erythromycin as a prokinetic agent has also been investigated recently for a range of
gastrointestinal motility disorders and more recently within the context of critically ill
patients. Azithromycin has a gastrointestinal motility stimulating effect; it has been known
for over 20 years that they act as a motilin receptor agonist in the gut and gallbladder
stimulating enteric nerves and smooth muscle and triggering a phase of the migrating
myoelectric complex. The antral motor effects of erythromycin A in humans are mediated via
different pathways. The induction of a premature activity is mediated through activation of
an intrinsic cholinergic pathway, while the induction of enhanced antral contractile activity
may be mediated via a pathway potentially involving activation of non muscular receptor.
Different doses of azithromycin may have different effects - as suggested in studies in
patients with diabetic gastro-paresis.
Forty mg azithromycin elicited a premature phase 3 complex that started in the stomach and
migrated to the small intestine, while doses of 200 and 350 mg erythromycin A elicited a
burst of antral phase-3-like contractions that did not migrate to the small intestine, but
were followed by a prolonged period of antral contractile activity.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06045078 -
Aromatherapy in Total Knee Replacement
|
N/A | |
| Completed |
NCT03297021 -
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
|
Phase 4 | |
| Recruiting |
NCT04182828 -
Effect of Intravenous Lidocaine on Immediate Post-operative Pain, Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Placebo Controlled Trial
|
Phase 4 | |
| Recruiting |
NCT04046068 -
Multimodal Perioperative Pain Management: ComfortSafe Program
|
||
| Withdrawn |
NCT01394536 -
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
|
N/A | |
| Completed |
NCT00231777 -
A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)
|
Phase 3 | |
| Active, not recruiting |
NCT02473042 -
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
|
N/A | |
| Recruiting |
NCT05759481 -
Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
|
Phase 2 | |
| Completed |
NCT03435003 -
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
|
Phase 4 | |
| Completed |
NCT02881840 -
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00231478 -
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
|
Phase 4 |