Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05533281

Enrollment

200

Registered

2022-09-09

Start date

2022-09-15

Completion date

2023-11-03

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting

Keywords

tramadol, nausea and vomiting

Brief summary

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

Interventions

DRUGtropisetron

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

DRUGmetoclopramide

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.

DRUGdexamethasone

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.

OTHERnormal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
NRS score of nausea and vomiting	From before administration to 10min after administration	NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)

Secondary

Measure	Time frame	Description
Incidence of postoperative nausea and vomiting	From end of operation to 24 hours after operation	PONV is recorded according to whether the patient present nausea and vomiting during the follow-up visits after surgery
NRS score of postoperative nausea and vomiting	From end of operation to 24 hours after operation	NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
Incidence of extra treatment for postoperative nausea and vomiting	From end of operation to 24 hours after operation	Incidence of extra treatment for postoperative nausea and vomiting was assessed by whether patient using other treatment for postoperative nausea and vomiting during the the follow-up visits after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026