Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

NCT ID: NCT03933605

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-02-08

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea Postoperative Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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midazolam and palonosetron

0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction

Group Type ACTIVE_COMPARATOR

midazolam and palonosetron group

Intervention Type DRUG

intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting

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

Group Type ACTIVE_COMPARATOR

palonosetron group

Intervention Type DRUG

intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Interventions

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midazolam and palonosetron group

intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting

Intervention Type DRUG

palonosetron group

intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Eun Kyung Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eun kyung Choi

Daegu, Korea (the Republic Of), South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YUMC 2017-04-030

Identifier Type: -

Identifier Source: org_study_id

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