NCT02944942

Brief Summary

General anesthetic technique plays a key role in most surgical procedures. This technique has some complications especially postoperative nausea/vomiting (PONV). This complication can lead to serious problems. Department of Anesthesiology has developed and implemented a PONV prophylaxis guideline for high risk PONV patients but PONV still remains.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

October 25, 2016

Last Update Submit

February 28, 2017

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomiting

    through study completion, an average of 24 hours

Study Arms (1)

Postoperative nausea and vomiting

Group 1: Patients undergoing general anesthesia with postoperative nausea and vomiting Group 2: Patients undergoing general anesthesia without postoperative nausea and vomiting

Procedure: General anesthesia

Interventions

General anesthesiaPROCEDURE

Patients undergoing general anesthesia

Postoperative nausea and vomiting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective surgery under general anesthesia

You may qualify if:

  • ASA classification I-III

You may not qualify if:

  • Incomplete or illegible medical records
  • Patients who underwent cardio-thoracic surgery
  • Patient who had chronic treatment with antiemetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (5)

  • Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

    PMID: 10485781RESULT

  • Blanc VF, Ruest P, Milot J, Jacob JL, Tang A. Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgery. Can J Anaesth. 1991 Jan;38(1):54-60. doi: 10.1007/BF03009164.

    PMID: 1989740RESULT

  • Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.

    PMID: 22110499RESULT

  • Doubravska L, Dostalova K, Fritscherova S, Zapletalova J, Adamus M. Incidence of postoperative nausea and vomiting in patients at a university hospital. Where are we today? Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2010 Mar;154(1):69-76. doi: 10.5507/bp.2010.012.

    PMID: 20445713RESULT

  • Jokinen J, Smith AF, Roewer N, Eberhart LH, Kranke P. Management of postoperative nausea and vomiting: how to deal with refractory PONV. Anesthesiol Clin. 2012 Sep;30(3):481-93. doi: 10.1016/j.anclin.2012.07.003. Epub 2012 Aug 14.

    PMID: 22989590RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Sirirat Tribuddharat, MD

    Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 26, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)