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

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02416115

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Ramosetron Drug: Naloxone Drug: saline Drug: Morphine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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: Naloxone Naloxone added to PCA was given iv. Drug: saline Saline was given iv. Drug: Morphine Morphine in the PCA 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: Naloxone Naloxone added to PCA was given iv. Drug: Morphine Morphine in the PCA was given iv.

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: Naloxone

Naloxone added to PCA was given iv.

Drug: saline

Saline was given iv.

Drug: Morphine

Morphine in the PCA 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: Naloxone

Naloxone added to PCA was given iv.

Drug: Morphine

Morphine in the PCA was given iv.

Outcome Measures

Primary Outcome Measures

The number of participants with postoperative nausea and vomiting [24 hours]
The number of participants with postoperative nausea and vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.