Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

NCT05533281 | Completed Phase 4 DMC

• 1 other identifier: Nausea and vomiting
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Nausea and Vomiting

Keywords

tramadol; nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• NRS score of nausea and vomiting

  NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)

  From before administration to 10min after administration

Secondary Outcomes (3)

• Incidence of postoperative nausea and vomiting

  From end of operation to 24 hours after operation

• NRS score of postoperative nausea and vomiting

  From end of operation to 24 hours after operation

• Incidence of extra treatment for postoperative nausea and vomiting

  From end of operation to 24 hours after operation

Study Arms (4)

tropisetron

EXPERIMENTAL

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

Drug: tropisetron

metoclopramide

EXPERIMENTAL

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

Drug: metoclopramide

dexamethasone

EXPERIMENTAL

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

Drug: dexamethasone

normal saline

PLACEBO COMPARATOR

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

Other: normal saline

Interventions

tropisetron 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.

tropisetron

metoclopramide 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.

metoclopramide

dexamethasone 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.

dexamethasone

normal saline 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.

normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists classification I-II
• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Tropisetron; Metoclopramide; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Guangyou Duan, MD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 15, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 3, 2023
• Last Updated: April 2, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)