NauseaNCT02049619
Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting
A study testing pharyngeal pack in people with Nausea and Vomiting, run by China Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- pharyngeal pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- undergoing elective orthognathic surgery
- age 18-50 year olds
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School & Hospital of Stomatology, China Medical University
Shenyang, Liaoning, 110002
xia zhang, MD, 8624 22892645, zhangxiamd@126.com
About this study
Official title: Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.
The purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.
Read the 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.
- Being tested
- pharyngeal pack
- Keywords
- Pharyngeal pack, Nausea, Vomiting, orthognathic surgery, maxillary osteotomy
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: pharyngeal pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first 24 postoperative hours
Secondary outcomes (3)
The incidence and severity of throat pain
0 represented no throat pain and 10 represented the most severe throat pain possible.
Measured: the first 24 postoperative hours
the incidence of oral mucosal injury
Measured: the first 24 postoperative hours
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
Measured: the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Zhang, China Medical University, China
- Investigators
- xia zhang, MD, Principal investigator, School & Hospital of Stomatology, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049619
- Sponsor's protocol ID
- UMC-PONV
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2014
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Pharyngeal Packs During Orthognathic Surgery Reduce Postoperative Nausea and Vomiting. A Prospective Randomized Double Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT02049619
- Acronym / sponsor ID
- UMC-PONV
- Keywords
- Pharyngeal pack, Nausea, Vomiting, orthognathic surgery, maxillary osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Following endotracheal intubation, no pharyngeal pack was inserted into the hypopharynx. |
| pharyngeal pack | Experimental | Device: pharyngeal packFollowing 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- undergoing elective orthognathic surgery
- age 18-50 year olds
- signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharyngeal packFollowing 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 |
Primary outcome
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
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.
3 secondary outcomes
The incidence and severity of throat pain
Time frame: the first 24 postoperative hours
the incidence of oral mucosal injury
Time frame: the first 24 postoperative hours
satisfactory scores of patients
Time frame: the first 24 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xia zhang, MD principal investigator
School & Hospital of Stomatology, China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharyngeal pack in people with Nausea and Vomiting, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xia zhang, MD (8624 22892645, zhangxiamd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.