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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Ramosetron; Drug: Morphine; Drug: Naloxone; Drug: saline

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: naloxone; PONV; ramosetron
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Serotonin Agents; Serotonin Antagonists; Narcotic Antagonists; Naloxone; Morphine; Ramosetron
• Other Study ID Numbers: KNUMC-14-1037