Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

NCT ID: NCT05533281

Last Updated: 2024-04-02

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-11-03

Brief Summary

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To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection

Detailed Description

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Conditions

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Nausea and 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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tropisetron

Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.

Group Type EXPERIMENTAL

tropisetron

Intervention Type DRUG

One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.

metoclopramide

Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Group Type EXPERIMENTAL

metoclopramide

Intervention Type DRUG

One dose of metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

dexamethasone

Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

One dose of dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

normal saline

Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Interventions

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tropisetron

One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.

Intervention Type DRUG

metoclopramide

One dose of metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Intervention Type DRUG

dexamethasone

One dose of dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Intervention Type DRUG

normal saline

Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists classification I-II
* 18.5≤BMI≤28
* Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
* Voluntarily and be able to understand and sign the informed consent form

Exclusion Criteria

* Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
* History of allergy to opioids
* Patients with a history or family history of epilepsy that has not been controlled by treatment
* Sedatives and antidepressants were used 24 hours before surgery
* Failure to cooperate with the study for any reason or in the opinion of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guangyou Duan, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

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The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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Nausea and vomiting

Identifier Type: -

Identifier Source: org_study_id

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