Incidence of Postoperative Nausea and VomitingPhase 4NCT02286752
Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
A Phase 4 study testing Neostigmine and sugammadex in people with Incidence of Postoperative Nausea and Vomiting, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Incidence of Postoperative Nausea and Vomiting
- What is being tested?
- Neostigmine and sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- endotracheal intubation and general anesthesia scheduled for elective surgery
Who cannot join
- age < 18 years, > 65 years
- pregnancy
- refusal to participate and patients already participating in another study
- allergy to study drugs
- communication difficulty
- psychiatric and neurological disorders
Show all 12Show fewer
- use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.
- emergency surgery
- history of drug or alcohol abuse
- ASA 3 and above
- patients with vertigo
- Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100
About this study
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.
It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.
Read more
Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.
The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.
- Being tested
- Neostigmine, sugammadex
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine
sugammadexDrug
for reversal of neuromuscular block: sugammadex 2 mg kg-1
| Study group | Role | What they receive |
|---|---|---|
| neostigmine | Active comparator | Not described Receives: Drug: Neostigmine |
| sugammadex | Active comparator | Not described Receives: Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Descriptive Scale
0: no nausea 1: mild 2: moderate 3: severe
Measured: within postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Postoperative Nausea and VomitingStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286752
- Sponsor's protocol ID
- Odu-6
- Status last verified
- Jan 2015
- First submitted
- 3 Nov 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
- ClinicalTrials.gov ID
- NCT02286752
- Acronym / sponsor ID
- Odu-6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Nov 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.
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.
It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.
Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.
The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neostigmine | Active comparator | Drug: Neostigmine |
| sugammadex | Active comparator | Drug: sugammadex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- endotracheal intubation and general anesthesia scheduled for elective surgery
Key exclusion criteria (12 listed)
- age < 18 years, > 65 years
- pregnancy
- refusal to participate and patients already participating in another study
- allergy to study drugs
- communication difficulty
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 |
|---|---|---|
| Neostigminefor reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine | Drug | neostigmine |
| sugammadexfor reversal of neuromuscular block: sugammadex 2 mg kg-1 | Drug | sugammadex |
Primary outcome
Verbal Descriptive Scale
Time frame: within postoperative 24 hours
0: no nausea 1: mild 2: moderate 3: severe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neostigmine and sugammadex in people with Incidence of Postoperative Nausea and Vomiting, run by Ordu University at 1 site in Turkey (Türkiye).
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jan 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Descriptive Scale (time frame: within postoperative 24 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 13 Jan 2015.