An interventional study of Ramosetron and Naloxone in Postoperative Nausea and Vomiting, sponsored by Kyungpook National University Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2016-02-22.
Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Prevention
Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after general anesthesia, and may lead to increased hospital stay and health care costs. The risk factors for PONV include sex (female population), nonsmoking status, past history of motion sickness and/or previous PONV, duration of anesthesia and surgical type (particular gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has been reported to be 30% with considerable variability, but can increase up to 69%- 80% in women undergoing gynecologic surgery with general anesthesia and morphine-patient controlled analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first line therapies for preventing PONV because of their efficacy and few side effects compared with other antiemetics. However, despite the use of this treatment, the incidence of PONV has been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects of opioid. It was found that administration of low dose naloxone prevents opioid side effects such as nausea and pruritus without affecting analgesia or opioid requirements in patient receiving morphine PCA. It was reported that the use of two antiemetic acting at different mechanisms is better to prevent PONV than monotherapy.
Therefore, this prospective, randomized, controlled study was designed to investigate the antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine PCA after gynecologic surgery.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's enrollment of 90 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
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Thirty minutes before end of surgery, patients in R group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, patients in R group received PCA morphine 1 mg/ml
Drug: Ramosetron · Drug: Morphine
Thirty minutes before end of surgery, patients in N group (n=30) received normal saline. In the post anesthetic care unit, group N received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml.
Drug: Naloxone · Drug: saline · Drug: Morphine
Thirty minutes before end of surgery, patients in Ramosetron and naloxone (RN) group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, group RN received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml.
Drug: Ramosetron · Drug: Naloxone · Drug: Morphine
Ramosetron was given iv.
Naloxone added to PCA was given iv.
Saline was given iv.
Morphine in the PCA was given iv.
The number of participants with postoperative nausea and vomiting
The number of participants with postoperative nausea and vomiting
Time frame: 24 hours
No study locations are listed for this record.
The record gives a start of Jul 2014, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ramosetron · Naloxone
Postoperative Nausea and Vomiting →
Kyungpook National University Hospital