Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03933605

Recruitment Status : Completed

First Posted : May 1, 2019

Last Update Posted : May 1, 2019

Sponsor:

Information provided by (Responsible Party):

Eun Kyung Choi, Yeungnam University College of Medicine

Study Description

Brief Summary:

In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.

Condition or disease	Intervention/treatment	Phase
Postoperative Nausea Postoperative Vomiting	Drug: midazolam and palonosetron group Drug: palonosetron group	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	88 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Actual Study Start Date :	July 10, 2017
Actual Primary Completion Date :	February 1, 2019
Actual Study Completion Date :	February 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Palonosetron

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: midazolam and palonosetron 0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction	Drug: midazolam and palonosetron group intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
Active Comparator: palonosetron the same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction	Drug: palonosetron group intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Outcome Measures

Primary Outcome Measures :

incidence of postoperative nausea and vomiting [ Time Frame: 24 hours after surgery ]
0=none; 1=occur
severity of postoperative nausea and vomiting [ Time Frame: 24 hours after surgery ]
0 = absent; 1 = mild; 2 = moderate; 3 = severe

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion Criteria:

The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933605

Locations

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Korea, Republic of
Eun kyung Choi
Daegu, Korea (the Republic Of), Korea, Republic of, 41944

Sponsors and Collaborators

Yeungnam University College of Medicine

More Information

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Responsible Party:	Eun Kyung Choi, Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier:	NCT03933605
Other Study ID Numbers:	YUMC 2017-04-030
First Posted:	May 1, 2019 Key Record Dates
Last Update Posted:	May 1, 2019
Last Verified:	April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Eun Kyung Choi, Yeungnam University College of Medicine:


postoperative nausea and vomiting midazolam palonosetron

Additional relevant MeSH terms:

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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Midazolam Palonosetron Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs	Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents

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