Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID06411665

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting in Laparoscopic Colorectal Surgery: A Randomized Trial

Led by Peking University First Hospital · Updated on 2024-10-08

252

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative nausea and vomiting (PONV) commonly occur after surgery and can delay recovery. Patients undergoing laparoscopic colorectal surgery face a higher risk of PONV due to factors like pneumoperitoneum, gastrointestinal interruption, delayed oral feeding, nasogastric catheterization, and opioid pain control. Researchers are studying whether oliceridine, a novel selective µ-opioid agonist that activates G protein signaling but less so β-arrestin recruitment, can reduce PONV compared to morphine in these patients. This trial compares two patient-controlled intravenous analgesia treatments given immediately after surgery: oliceridine and morphine. Both drugs are delivered using pumps programmed to provide 2-ml boluses with a 10-minute lockout interval and a background infusion rate of 1 ml per hour, used for three days post-surgery. The doses are 15 mg oliceridine diluted to 100 ml and 50 mg morphine diluted to 100 ml. Participants will be monitored for up to 72 hours after surgery to track the incidence of PONV, vomiting, nausea intensity, and pain levels at rest and with movement. Quality of recovery will be assessed at 24 and 72 hours, and time to first flatus within five days will be recorded. This randomized, triple-blind trial aims to provide detailed safety and efficacy information during the critical postoperative period.

CONDITIONS

Brief Title

Effect of Oliceridine Analgesia on Postoperative Nause and Vomiting

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 80 years
  • Scheduled to undergo elective laparoscopic colorectal surgery
  • Required patient-controlled intravenous analgesia
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Severe heart dysfunction (New York Heart Association functional classification 4), hepatic insufficiency (Child-Pugh grade C), renal insufficiency (serum creatinine of 442 bcmol/L or above, or requirement of renal replacement therapy), or American Society of Anesthesiologists classification IV or above
  • Unable to complete preoperative assessment due to severe dementia or language barrier
  • Other conditions that are considered unsuitable for study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 days

Participants receive patient-controlled intravenous analgesia with either oliceridine or morphine for up to 3 days after laparoscopic colorectal surgery to manage pain and study its effects on postoperative nausea and vomiting.

1 baseline visit and daily visits during the 3 days after surgery

Follow-up

Duration - Up to 5 days

Participants are monitored for postoperative nausea and vomiting, pain intensity, quality of recovery, and time to first flatus up to 5 days after surgery.

Approximately 3 follow-up visits after treatment

Trial Site Locations

Total: 1 location

1

Dong-Xin Wang

Beijing, China, 100034

Actively Recruiting

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Research Team

X

Xue Li, M.D.

D

Dong-Xin Wang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Postoperative Nausea and Vomiting Prediction: Machine Learning Insights from a Comprehensive Analysis of Perioperative Data.

Jong-Ho Kim, Bo-Reum Cheon, Min-Guan Kim...

https://pubmed.ncbi.nlm.nih.gov/37892882

Remimazolam's Effects on Postoperative Nausea and Vomiting Are Similar to Those of Propofol after Laparoscopic Gynecological Surgery: A Randomized Controlled Trial.

Ayumu Matsumoto, Shiho Satomi, Nami Kakuta...

https://pubmed.ncbi.nlm.nih.gov/37629444

Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial).

DREAMS Trial Collaborators and West Midlands Research Collaborative

https://pubmed.ncbi.nlm.nih.gov/28420629

Incidence and risk factors of postoperative nausea and vomiting following laparoscopic sleeve gastrectomy and its relationship with Helicobacter pylori: A propensity score matching analysis.

Yali Song, Jie Zhu, Zhiyong Dong...

https://pubmed.ncbi.nlm.nih.gov/36909334

Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS®) Society Recommendations: 2018.

U O Gustafsson, M J Scott, M Hubner...

https://pubmed.ncbi.nlm.nih.gov/30426190

Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis.

Ashraf S Habib, Ya-Ting Chen, Akiko Taguchi...

https://pubmed.ncbi.nlm.nih.gov/16846542

Association between intra-operative fentanyl dosing and postoperative nausea/vomiting and pain: A prospective cohort study.

Eckhard Mauermann, Damian Clamer, Wilhelm Ruppen...

https://pubmed.ncbi.nlm.nih.gov/31567573