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Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Primary Purpose

Nausea and Vomiting

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
tropisetron
metoclopramide
dexamethasone
normal saline
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea and Vomiting focused on measuring tramadol, nausea and vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists classification I-II
  • 18.5≤BMI≤28
  • Patients who require 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

Sites / Locations

  • The Second Affiliated Hospital, Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

tropisetron

metoclopramide

dexamethasone

normal saline

Arm Description

Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed within 1min.

Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.

Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Incidence of postoperative nausea and vomiting
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
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
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

Full Information

First Posted
September 6, 2022
Last Updated
December 27, 2022
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05533281
Brief Title
Efficacy of Three Antiemetics in Preventing Nausea and Vomiting
Official Title
Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Anticipated)
Study Completion Date
February 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting
Keywords
tramadol, nausea and vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tropisetron
Arm Type
Experimental
Arm Description
Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed within 1min.
Arm Title
metoclopramide
Arm Type
Experimental
Arm Description
Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.
Arm Title
dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed within 1min.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously within one minute to ensure constant speed.
Intervention Type
Drug
Intervention Name(s)
tropisetron
Intervention Description
One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed within 1min.
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
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 within 1min.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
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 within 1min.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
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 within 1min.
Primary Outcome Measure Information:
Title
NRS score of nausea and vomiting
Description
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
Time Frame
From before administration to 10min after administration
Secondary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
PONV is recorded according to whether the patient present nausea and vomiting during the follow-up visits after surgery
Time Frame
From end of operation to 24 hours after operation
Title
NRS score of postoperative nausea and vomiting
Description
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
Time Frame
From end of operation to 24 hours after operation
Title
Incidence of extra treatment for postoperative nausea and vomiting
Description
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
Time Frame
From end of operation to 24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists classification I-II 18.5≤BMI≤28 Patients who require 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangyou Duan, MD
Phone
(+86)18323376014
Email
duangy@hospital.cqmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
The Second Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyou Duan, MD
Phone
(+86)18323376014
Email
duangy@hospital.cqmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data for this study is available from the sponsor on reasonable request through email.

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Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

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