Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting

NCT ID: NCT00193999

Last Updated: 2009-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-05-31

Brief Summary

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Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.

Detailed Description

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Conditions

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Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Placement of nasogastric tube

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* undergoing coronary artery bypass graft and/or valvular surgery,
* age 18-80 year olds
* signed informed consent
* elective or urgent surgery

Exclusion Criteria

* past history of oesophageal surgery, oesophageal varices or stricture,
* patients who have received antiemetic medication in the 24 hours before surgery
* emergency surgery
* patients that require re-sternotomy, or are not extubated 24 hours after admission to the intensive care unit, will be excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Toronto General Hospital, University Health Network

Principal Investigators

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George Djaiani, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Djaiani G, Katznelson R, Fedorko L, Rao V, Green R, Carroll J, Katski J. Early benefit of preserved cognitive function is not sustained at one-year after cardiac surgery: a longitudinal follow-up of the randomized controlled trial. Can J Anaesth. 2012 May;59(5):449-55. doi: 10.1007/s12630-012-9675-y.

Reference Type DERIVED
PMID: 22290354 (View on PubMed)

Other Identifiers

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UHN REB 02-0601-B

Identifier Type: -

Identifier Source: org_study_id

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