Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting

Nausea Clinical Trial

Official title:

Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02049619
• Other study ID #: UMC-PONV
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2014
• Last updated: February 4, 2015
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2015
• Source: China Medical University, China
• Contact: xia zhang, MD
• Phone: 8624 22892645
• Email: zhangxiamd[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
China	School & Hospital of Stomatology, China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The incidence and severity of throat pain	0 represented no throat pain and 10 represented the most severe throat pain possible.	the first 24 postoperative hours	Yes
Secondary	the incidence of oral mucosal injury		the first 24 postoperative hours	Yes
Secondary	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	the first 24 postoperative hours	Yes