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Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

Primary Purpose

Nausea, Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pharyngeal pack
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Pharyngeal pack, Nausea, Vomiting, orthognathic surgery, maxillary osteotomy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • School & Hospital of Stomatology, China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

pharyngeal pack

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The incidence and severity of throat pain
0 represented no throat pain and 10 represented the most severe throat pain possible.
the incidence of oral mucosal injury
satisfactory scores of patients
0 represented that patients are not satisfactory with the anesthesia and 10 represented that patients are very satisfactory with the anesthesia

Full Information

First Posted
January 27, 2014
Last Updated
February 4, 2015
Sponsor
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02049619
Brief Title
Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting
Official Title
Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.
Detailed Description
Post-operative nausea and vomiting (PONV) is one of the most frequent and distressing complications of anesthesia. Patients often rate that PONV is worse than postoperative pain. PONV alone is one of the leading causes for delayed discharge and unpleasant experiments. Although PONV is not always life-threatening, persistent cases can result in dehydration, esophageal rupture, aspiration and potential death. The massive ingested blood and the additional issue of an altered diet (full liquids) due to a short period of jaw immobilization may be associated with a higher prevalence of PONV after orthognathic surgeries. Although most of antiemetic drugs can help prevent PONV, they cannot preclude vomiting resulting from irritating gastrointestinal stimuli such as blood in the stomach. Pharyngeal packs are thought to prevent the ingestion and aspiration of blood, cartilage and bone fragments during oral and maxillofacial surgeries. Whether pharyngeal packs can reduce the incidence of PONV is controversial. It is reported that pharyngeal packs are recommended for the purpose of preventing PONV in nasal surgeries. However, some authors suggest that pharyngeal packs have no impact on PONV or the prevalence of PONV is doubled during routine nasal surgeries. However, the population size in these studies is relatively small and the trials have significant methodological weakness. None of these trials totally addressed the issue of the pharyngeal packs on the PONV following nasal surgeries. Moreover, these studies include different types of nasal surgeries, not all of which can be assumed to have equivalent bleeding potential. Orthognathic surgeries performed maxillary and mandibular osteotomies and are assumed to involve massive blood loss. Orofacial swelling and swallowing blood is common in the early postoperative period after orthognathic surgeries. Whether pharyngeal packs can reduce the swallowing blood and PONV is unknown. Thus, The objective of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Pharyngeal pack, Nausea, Vomiting, orthognathic surgery, maxillary osteotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Following endotracheal intubation, no pharyngeal pack was inserted into the hypopharynx.
Arm Title
pharyngeal pack
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
pharyngeal pack
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
the first 24 postoperative hours
Secondary Outcome Measure Information:
Title
The incidence and severity of throat pain
Description
0 represented no throat pain and 10 represented the most severe throat pain possible.
Time Frame
the first 24 postoperative hours
Title
the incidence of oral mucosal injury
Time Frame
the first 24 postoperative hours
Title
satisfactory scores of patients
Description
0 represented that patients are not satisfactory with the anesthesia and 10 represented that patients are very satisfactory with the anesthesia
Time Frame
the first 24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing elective orthognathic surgery age 18-50 year olds signed informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xia zhang, MD
Phone
8624 22892645
Email
zhangxiamd@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xia zhang, MD
Organizational Affiliation
School & Hospital of Stomatology, China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
School & Hospital of Stomatology, China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xia zhang, MD
Phone
8624 22892645
Email
zhangxiamd@126.com

12. IPD Sharing Statement

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Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

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