Clinical trial NCT03641625: Effect of SmtO2 Guided Care on PONV (iMODIPONV)
Official title: Effect of Muscular Tissue Oxygen Saturation-Guided Management During Laparoscopic Hysterectomy on Postoperative Nausea and Vomiting: A Randomized Controlled Trial (iMODIPONV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Hysterectomy
Tissue Oxygenation
Cardiac Output Management
Blood Pressure Management
Keywords: Postoperative Nausea and Vomiting
Laparoscopic Hysterectomy
Muscular Tissue Oxygen Saturation
Hemodynamic Management
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Peking University First Hospital
name: Peking University Third Hospital
name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Beijing Obstetrics and Gynecology Hospital
First posted: 2018-08-22
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International, multi-center, pragmatic, randomized controlled (1:1 ratio) trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years
2. Non-smoker
3. ASA I-III
4. Elective laparoscopic procedure involving hysterectomy

Exclusion Criteria:

1. Refuse to participate
2. Emergent surgery
3. Bowel resection planned
4. Vaginal or abdominal (open) hysterectomy
5. Chemotherapy or radiotherapy before surgery
6. Significant neuro, cognitive, or psychologic disease: stroke with neurologic deficit, dementia, schizophrenia, or any condition that makes meaningful postoperative follow-ups impossible
7. Significant cardiovascular disease: low-output cardiac failure defined as a preoperative left ventricular ejection fraction \< 30%, active coronary artery disease, symptomatic valvular disease, symptomatic arrhythmia with or without pacemaker and/or AICD placement
8. Significant pulmonary disease: COPD requiring home oxygen therapy, severe asthma requiring steroid treatment, other pulmonary conditions requiring home oxygen therapy
9. Severe hepatic dysfunction being evaluated for liver transplantation or with a Child-Pugh Class C classification
10. Severe renal dysfunction requiring renal replacement therapy
11. Muscular pathologies such as dystrophy, atrophy, and weakness
12. Skin conditions incompatible with the adhesive oximetry probe (e.g., delicate or tattooed skin)
13. Current or previous smoker
14. ASA Physical Score ≥ IV

Primary outcomes:
measure: Incidence of PONV within 24 hours after surgery
timeFrame: up to 24 hours
Secondary outcomes:
measure: Incidence of early PONV
timeFrame: up to 6 hours
measure: Severity of postoperative pain
timeFrame: up to 24 hours
measure: Time of GI recovery
timeFrame: up to 48 hours
measure: Overall quality of recovery based on QoR-15 questionnaire
timeFrame: up to 24 hours
measure: Time to mobilization
timeFrame: up to 48 hours
measure: Score of sleep quality
timeFrame: up to 48 hours
measure: In-hospital GI complications
timeFrame: up to 30 days
measure: Non-GI-related composite complications
timeFrame: up to 30 days
measure: Length of hospital stay
timeFrame: up to 30 days
measure: Rate of ICU admission
timeFrame: Up to 30 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Yale University
name: Lingzhong Meng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geng ZY, Liu YF, Wang SS, Wang DX. Intra-operative dexmedetomidine reduces early postoperative nausea but not vomiting in adult patients after gynaecological laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Oct;33(10):761-6. doi: 10.1097/EJA.0000000000000491.
citation: Gan TJ, Mythen MG. Does peroperative gut-mucosa hypoperfusion cause postoperative nausea and vomiting? Lancet. 1995 Apr 29;345(8957):1123-4. doi: 10.1016/s0140-6736(95)90857-9. No abstract available.
citation: Meng L, Xiao J, Gudelunas K, Yu Z, Zhong Z, Hu X. Association of intraoperative cerebral and muscular tissue oxygen saturation with postoperative complications and length of hospital stay after major spine surgery: an observational study. Br J Anaesth. 2017 Apr 1;118(4):551-562. doi: 10.1093/bja/aex008.
citation: Zhao X, Liao K, Wang W, Xu J, Meng L. Can a deep learning model based on intraoperative time-series monitoring data predict post-hysterectomy quality of recovery? Perioper Med (Lond). 2021 Apr 6;10(1):8. doi: 10.1186/s13741-021-00178-4.