NCT02049619

Brief Summary

The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

January 27, 2014

Last Update Submit

February 4, 2015

Conditions

NauseaVomiting

Keywords

Pharyngeal packNauseaVomitingorthognathic surgerymaxillary osteotomy

Outcome Measures

Primary Outcomes (1)

  • the incidence and severity of any nausea, emetic episodes (retching or vomiting), or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.

    The primary outcome measure was the incidence and severity of any nausea, emetic episodes (retching or vomiting), or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours. After the 2nd, 4th, 6th and 24th postoperative hours, trained investigators who were fully blinded to the intraoperative management and random treatment assignments recorded the number of emetic episodes, the volume of vomiting, and the time each one occurred. 0 represented no PONV and 10 represented the most severe PONV possible.

    the first 24 postoperative hours

Secondary Outcomes (3)

  • The incidence and severity of throat pain

    the first 24 postoperative hours

  • the incidence of oral mucosal injury

    the first 24 postoperative hours

  • satisfactory scores of patients

    the first 24 postoperative hours

Study Arms (2)

Control

NO INTERVENTION

Following endotracheal intubation, no pharyngeal pack was inserted into the hypopharynx.

pharyngeal pack

EXPERIMENTAL

Following endotracheal intubation, one saline soaked, gauze pharyngeal pack was inserted into the hypopharynx under direct vision using McGill's forceps. The packs were tied to the endotracheal tube and their placements were documented on the scrub nurse's count board.

Device: pharyngeal pack

Interventions

pharyngeal packDEVICE

Following endotracheal intubation, one saline soaked, gauze pharyngeal pack was inserted into the hypopharynx under direct vision using McGill's forceps. The packs were tied to the endotracheal tube and their placements were documented on the scrub nurse's count board.

pharyngeal pack

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • undergoing elective orthognathic surgery
  • age 18-50 year olds
  • signed informed consent

You may not qualify if:

  • pregnant women
  • past history of oesophageal surgery, oesophageal varices or stricture,
  • patients who have received antiemetic medication in the 24 hours before surgery
  • emergency surgery
  • prior history of motion sickness and/or PONV, vertigo or migraine headaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

MeSH Terms

Conditions

NauseaVomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • xia zhang, MD

    School & Hospital of Stomatology, China Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xia zhang, MD

CONTACT

8624 22892645zhangxiamd@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 30, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

CN(1)