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Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

C

Chongqing Medical University

Status and phase

Completed
Phase 4

Conditions

Nausea and Vomiting

Treatments

Drug: tropisetron
Drug: metoclopramide
Drug: dexamethasone
Other: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05533281
Nausea and vomiting

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 4 patient groups, including a placebo group

tropisetron
Experimental group
Description:
Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.
Treatment:
Drug: tropisetron
metoclopramide
Experimental group
Description:
Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
Treatment:
Drug: metoclopramide
dexamethasone
Experimental group
Description:
Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
Treatment:
Drug: dexamethasone
normal saline
Placebo Comparator group
Description:
Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed.
Treatment:
Other: normal saline

Trial contacts and locations

1

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Central trial contact

Guangyou Duan, MD

Data sourced from clinicaltrials.gov

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