Postoperative Nausea and Vomiting Clinical Trial
Official title:
Effect of Muscular Tissue Oxygen Saturation-Guided Management During Laparoscopic Hysterectomy on Postoperative Nausea and Vomiting: A Randomized Controlled Trial (iMODIPONV)
This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV.
Postoperative nausea and vomiting (PONV) remains prevalent despite the institution of various
prophylactic measures. The incidence of PONV in female patients undergoing laparoscopic
gynecological surgery is up to 50% with and 70% without the administration of antiemetics,
respectively. The consequences of PONV range from patient discomforts, postoperative
complications, prolonged hospitalization, to increased health care costs. Among the multiple
risk factors, suboptimal gastrointestinal (GI) perfusion or oxygenation may be responsible
for some cases of PONV; however, this speculation remains to be confirmed.5 Optimal tissue
oxygenation, the balance between tissue oxygen consumption and supply, is essential for the
integrity of any tissue bed that is metabolically active. However, GI oxygenation cannot be
directly and continuously monitored in patients at this time. Whether there is an organ which
can be used as a surrogate of the GI system, meaning that the tissue oxygenation of this
surrogate organ not only can be monitored and that it also correlates with that of the GI
system, is an intriguing question. Currently, tissue oxygenation can be measured using
near-infrared spectroscopy (NIRS) in patients. The recent advancements of this technology
enable the accurate monitoring of the oxygenation within many tissue beds depending on the
location of the oximetry probe.
The recent cohort study demonstrated that there is a close relationship between muscular
tissue oxygen saturation (SmtO2) and PONV in patients undergoing robotic laparoscopic
hysterectomy (manuscript accepted and in production). Multiple thresholds based on threshold,
AUC, and multivariable analyses are able to differentiate the risk of PONV. The following
SmtO2 thresholds were found to correlate with a reduced risk of PONV: 20% above baseline;
while the following thresholds correlate with an increased risk of PONV: 5% below baseline,
15% below baseline, and 20% below baseline, < 70%, < 65%, and < 60%. Taken together, our
study suggests the potential therapeutic targets for PONV prophylaxis may be to maintain
SmtO2 > 70% and above baseline.
In this study, the investigators aim to investigate if intraoperative care guided by SmtO2
monitoring reduces the incidence of PONV after laparoscopic hysterectomy.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04466046 -
The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients
|
||
Completed |
NCT03139383 -
Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery
|
N/A | |
Recruiting |
NCT04069806 -
Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
|
N/A | |
Completed |
NCT04043247 -
Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting
|
N/A | |
Terminated |
NCT01975727 -
Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting
|
Phase 2 | |
Completed |
NCT03662672 -
Rib Raising for Post-operative Ileus
|
N/A | |
Completed |
NCT00090155 -
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
|
Phase 3 | |
Recruiting |
NCT05375721 -
Prevention of PONV With Traditional Chinese Medicine
|
N/A | |
Completed |
NCT02480088 -
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism
|
Phase 4 | |
Recruiting |
NCT06137027 -
Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting
|
Early Phase 1 | |
Not yet recruiting |
NCT05529004 -
A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
|
Phase 2 | |
Completed |
NCT02944942 -
Risk Factors for Postoperative Nausea/Vomiting
|
N/A | |
Recruiting |
NCT02571153 -
Low Doses of Ketamine and Postoperative Quality of Recovery
|
Phase 4 | |
Completed |
NCT02550795 -
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
|
N/A | |
Completed |
NCT02449291 -
Study of APD421 as PONV Treatment (no Prior Prophylaxis)
|
Phase 3 | |
Recruiting |
NCT01442012 -
Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
|
N/A | |
Completed |
NCT01478165 -
Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
|
N/A | |
Unknown status |
NCT01268748 -
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
|
N/A | |
Completed |
NCT02143531 -
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
|
Phase 4 | |
Completed |
NCT00734929 -
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
|
Phase 4 |