The Effect on Anxiolytics With Type of Antiemetic Agents... | NCT04466046

Studies
The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

NCT04466046

Sponsor

Daegu Catholic University Medical Center

Status

Completed

Last Update Posted

Nov 2, 2022Actual

Enrollment

68Actual

Phase

Not provided

Conditions

Postoperative Nausea and Vomiting

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2019Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jul 2, 2020

First Submission Date that Met QC Criteria

Jul 7, 2020

First Posted Date

Jul 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung A, Assistant professor, Daegu Catholic University Medical CenterPrincipal Investigator

Lead Sponsor

Daegu Catholic University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.

The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.

Detailed Description

This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.

0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PONV group		Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
no PONV group		Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients receiving ramosetron or palonosetron in each groups	percentage of patients receiving ramosetron or palonosetron	48 hours after surgery
severity of postoperative nausea in PONV group	0 = none, 1 = mild, 2 = moderate, 3 = severe	48 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
postoperative pain	numerical analog scale : 0 to 10	48 hours after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

pregnant or breast feeding patients
smokers
patients with history of chronic opioid abuse
hypersensitivity to 5-HT3 receptor antagonists or analgesics
those who were antiemetic or opioid treatment within 24 hours prior to surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic cholecystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung A Lim, MD	Daegu Catholic University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daegu Catholic University Medical Center		Daegu	Nam-gu	42472	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided