Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

NCT ID: NCT02049619

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

pharyngeal pack

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Xia Zhang

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xia zhang, MD

Role: PRINCIPAL_INVESTIGATOR

School & Hospital of Stomatology, China Medical University, China

Locations

School & Hospital of Stomatology, China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

xia zhang, MD

Role: CONTACT

zhangxiamd@126.com

8624 22892645

Facility Contacts

xia zhang, MD

Role: primary

zhangxiamd@126.com

8624 22892645

Other Identifiers

UMC-PONV

Identifier Type: -

Identifier Source: org_study_id