Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia After Gynecologic Surgery

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Ramosetron
* Drug: Naloxone
* Drug: saline
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsmoking women (ASA physical status of I or II) scheduled for gynecologic surgery under general anesthesia and postoperative analgesia with a PCA device were included Exclusion Criteria: known hypersensitivity to study medication; the use of antiemetics within 24 hours before surgery; the presence of gastrointestinal, renal, hepatic, or psychiatric disease.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R group<br>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<br>* Ramosetron was given iv.<br>Drug: Morphine<br>* Morphine in the PCA was given iv.<br>|
| Active Comparator: N group<br>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<br>* Naloxone added to PCA was given iv.<br>Drug: saline<br>* Saline was given iv.<br>Drug: Morphine<br>* Morphine in the PCA was given iv.<br>|
| Experimental: RN group<br>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<br>* Ramosetron was given iv.<br>Drug: Naloxone<br>* Naloxone added to PCA was given iv.<br>Drug: Morphine<br>* Morphine in the PCA was given iv.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with postoperative nausea and vomiting | The number of participants with postoperative nausea and vomiting | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, ramosetron, naloxone