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Completed

NCT Number: NCT05533281

Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

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

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Key information

Conditions

Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. NRS score of nausea and vomiting

    Time frame: 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 outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 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

  2. NRS score of postoperative nausea and vomiting

    Time frame: 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)

  3. Incidence of extra treatment for postoperative nausea and vomiting

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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