Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by China Medical University, China
Sponsor:
Information provided by (Responsible Party):
Xia Zhang, China Medical University, China
ClinicalTrials.gov Identifier:
NCT02049619
First received: January 27, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Nausea
Vomiting
Device: pharyngeal pack

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

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. [ Time Frame: the first 24 postoperative hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: the first 24 postoperative hours ] [ Designated as safety issue: Yes ]
    0 represented no throat pain and 10 represented the most severe throat pain possible.

  • the incidence of oral mucosal injury [ Time Frame: the first 24 postoperative hours ] [ Designated as safety issue: Yes ]
  • satisfactory scores of patients [ Time Frame: the first 24 postoperative hours ] [ Designated as safety issue: Yes ]
    0 represented that patients are not satisfactory with the anesthesia and 10 represented that patients are very satisfactory with the anesthesia


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Following endotracheal intubation, no pharyngeal pack was inserted into the hypopharynx.
Experimental: pharyngeal pack
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049619

Contacts
Contact: xia zhang, MD 8624 22892645 zhangxiamd@126.com

Locations
China, Liaoning
School & Hospital of Stomatology, China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110002
Contact: xia zhang, MD    8624 22892645    zhangxiamd@126.com   
Sponsors and Collaborators
China Medical University, China
Investigators
Principal Investigator: xia zhang, MD School & Hospital of Stomatology, China Medical University, China
  More Information

No publications provided

Responsible Party: Xia Zhang, assistant professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT02049619     History of Changes
Other Study ID Numbers: UMC-PONV
Study First Received: January 27, 2014
Last Updated: January 29, 2014
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
Pharyngeal pack
Nausea
Vomiting
orthognathic surgery
maxillary osteotomy

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014