Nausea and VomitingPhase 1NCT05837156
A Clinical Study to Evaluate Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting
A Phase 1 study testing Heptaflurane combined Cyclophenol, Heptaflurane and Cyclophenol in people with Nausea and Vomiting, run by Mengchang Yang at 1 site in China.
Trial summary
This study uses cyclopropofol as a positive control and adopts a large sample, multicenter, randomized, single-blind, positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- Heptaflurane combined Cyclophenol, Heptaflurane and Cyclophenol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 30 Dec 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 2 of the 4 induced risk factors of PONV (risk factors are: history of PONV or motion sickness, habitual non-smoking, women, receiving opioid analgesia).
- For patients with an estimated duration of anesthesia ≥1h and ≤3h (non-emergency, non-cardiothoracic surgery and non-intracranial surgery), laparoscopic surgery, gastrointestinal surgery, obstetrics and gynecology surgery, tympanoplasty, tonstonectomy, etc., are preferred. The duration of hand anesthesia was defined as the period from the beginning of anesthesia induction to the end of anesthesia maintenance
- Male or female, age ≥ 18 years old, ASA-PS score I to III.
Who cannot join
- There is a history of vestibular nerve disorder or dizziness or nausea and vomiting 24 hours before the operation; or receiving conventional antiemetic treatment.
- The subjects who need to maintain ventilation after surgery or need to place the nasogastric tube in place for a period of time.
- The subject who the researcher believes that there are any other factors that are not suitable to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study of Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting
This study uses cyclopropofol as a positive control and adopts a large sample, multicenter, randomized, single-blind, positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting.
Read the detailed description
Before the end of the anesthesia maintenance period/operation, it was divided into groups A, B and C according to different drug regimens. The subjects were randomly assigned to one of them in a 1:1:1 ratio to receive cyclopophenol or sevoflurane anesthesia. Each group of subjects should be roughly consistent according to the proportion of each number of PO . After screening the object, the researchers of each testing center are confirmed by the researchers of the center, log in to the random system, fill in the screening information, obtain the random number information, and distribute the corresponding research drugs according to the random number. The number of random shelters is generated through SAS software, which is used as a centralized random grouping system to import the total number of drugs. This study sets up evaluation researchers and drug management researchers. The whole experimental process turned a blind eye to not only the subjects, but also the evaluators. This study has set up evaluation investigators and administrative investigators. Administrative researchers are only involved in the random grouping, dispensing and delivery process. Other processes, including the subject's informed consent, screening, efficacy indicators and safety evaluation, and planned visits, are completed by the evaluation investigators.
- Conditions
- Nausea and Vomiting
- Being tested
- Heptaflurane combined Cyclophenol, Heptaflurane, Cyclophenol
- Keywords
- Cyclophenol, Heptaflurane
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heptaflurane combined CyclophenolDrug
Heptaflurane combined Cyclophenol
HeptafluraneDrug
Heptaflurane only
CyclophenolDrug
Cyclophenol only
| Study group | Role | What they receive |
|---|---|---|
| group cyclophenol | Active comparator | Calculated by body weight (kg), the initial dose of continuous infusion of cyclopophenol is 0.8 mg/kg/h. During the infusion, the researchers adjusted the rate according to the reaction of the subjects, and the adjustment range was 0.4 mg/kg/h-2.4 mg/kg/h. Receives: Drug: Cyclophenol |
| group heptaflurane | Active comparator | The anesthetic sevoflurane is inhaled for anesthesia maintenance. The initial concentration of sevoflurane is 1.5-2.0%, which can be adjusted to the expected effect according to the subject's reaction. Receives: Drug: Heptaflurane |
| group heptaflurane combined cyclophenol | Experimental | Inhaled anesthetic sevoflurane combined with a small dose of cyclopophenol for anesthesia maintenance. The initial concentration of sevoflurane is 0.5%, and the initial dose of cyclopophenol is 0.4 mg/kg/h.After that, sevoflurane or cyclopophenol (with an adjustment range of 0.2 mg/kg/h-1.2 mg/kg/h) can be adjusted to the expected effect according to the subject's reaction. Receives: Drug: Heptaflurane combined Cyclophenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PONV within 24 hours after each group's operation.
PONV incidence (%) = (number of patients with nausea and vomiting / number of PONV incidence (%) = (number of patients with nausea and vomiting / number of people in the group) × 100%
Measured: Day 1
Secondary outcomes (2)
The incidence of nausea and vomiting within 48 hours after surgery in each group
PONV incidence (%) = (number of patients with nausea and vomiting / number of PONV incidence (%) = (number of patients with nausea and vomiting / number of people in the group) × 100%
Measured: Day 2
The average number of rescues within 24 and 48 hours after surgery in each group
Severe vomiting (level 3 or above) requires rescue treatment
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start2 Aug 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mengchang Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837156
- Sponsor's protocol ID
- 950429
- Status last verified
- Jul 2023
- First submitted
- 2 Apr 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study of Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT05837156
- Acronym / sponsor ID
- 950429
- Conditions
- Nausea and Vomiting
- Keywords
- Cyclophenol, Heptaflurane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mengchang YangUniversity, hospital or other
- Study start
- 2 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 May 2023 (actual)
- 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.
This study uses cyclopropofol as a positive control and adopts a large sample, multicenter, randomized, single-blind, positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting.
Detailed description
Before the end of the anesthesia maintenance period/operation, it was divided into groups A, B and C according to different drug regimens. The subjects were randomly assigned to one of them in a 1:1:1 ratio to receive cyclopophenol or sevoflurane anesthesia. Each group of subjects should be roughly consistent according to the proportion of each number of PO . After screening the object, the researchers of each testing center are confirmed by the researchers of the center, log in to the random system, fill in the screening information, obtain the random number information, and distribute the corresponding research drugs according to the random number. The number of random shelters is generated through SAS software, which is used as a centralized random grouping system to import the total number of drugs. This study sets up evaluation researchers and drug management researchers. The whole experimental process turned a blind eye to not only the subjects, but also the evaluators. This study has set up evaluation investigators and administrative investigators. Administrative researchers are only involved in the random grouping, dispensing and delivery process. Other processes, including the subject's informed consent, screening, efficacy indicators and safety evaluation, and planned visits, are completed by the evaluation investigators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group cyclophenol | Active comparator | Drug: CyclophenolCalculated by body weight (kg), the initial dose of continuous infusion of cyclopophenol is 0.8 mg/kg/h. During the infusion, the researchers adjusted the rate according to the reaction of the subjects, and the adjustment range was 0.4 mg/kg/h-2.4 mg/kg/h. |
| group heptaflurane | Active comparator | Drug: HeptafluraneThe anesthetic sevoflurane is inhaled for anesthesia maintenance. The initial concentration of sevoflurane is 1.5-2.0%, which can be adjusted to the expected effect according to the subject's reaction. |
| group heptaflurane combined cyclophenol | Experimental | Drug: Heptaflurane combined CyclophenolInhaled anesthetic sevoflurane combined with a small dose of cyclopophenol for anesthesia maintenance. The initial concentration of sevoflurane is 0.5%, and the initial dose of cyclopophenol is 0.4 mg/kg/h.After that, sevoflurane or cyclopophenol (with an adjustment range of 0.2 mg/kg/h-1.2 mg/kg/h) can be adjusted to the expected effect according to the subject's reaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 2 of the 4 induced risk factors of PONV (risk factors are: history of PONV or motion sickness, habitual non-smoking, women, receiving opioid analgesia).
- For patients with an estimated duration of anesthesia ≥1h and ≤3h (non-emergency, non-cardiothoracic surgery and non-intracranial surgery), laparoscopic surgery, gastrointestinal surgery, obstetrics and gynecology surgery, tympanoplasty, tonstonectomy, etc., are preferred. The duration of hand anesthesia was defined as the period from the beginning of anesthesia induction to the end of anesthesia maintenance
- Male or female, age ≥ 18 years old, ASA-PS score I to III.
Key exclusion criteria (3 listed)
- There is a history of vestibular nerve disorder or dizziness or nausea and vomiting 24 hours before the operation; or receiving conventional antiemetic treatment.
- The subjects who need to maintain ventilation after surgery or need to place the nasogastric tube in place for a period of time.
- The subject who the researcher believes that there are any other factors that are not suitable to participate in the research.
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 |
|---|---|---|
| Heptaflurane combined CyclophenolHeptaflurane combined Cyclophenol | Drug | group heptaflurane combined cyclophenol |
| HeptafluraneHeptaflurane only | Drug | group heptaflurane |
| CyclophenolCyclophenol only | Drug | group cyclophenol |
Primary outcome
The incidence of PONV within 24 hours after each group's operation.
Time frame: Day 1
PONV incidence (%) = (number of patients with nausea and vomiting / number of PONV incidence (%) = (number of patients with nausea and vomiting / number of people in the group) × 100%
2 secondary outcomes
The incidence of nausea and vomiting within 48 hours after surgery in each group
Time frame: Day 2
The average number of rescues within 24 and 48 hours after surgery in each group
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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 1 study testing Heptaflurane combined Cyclophenol, Heptaflurane and Cyclophenol in people with Nausea and Vomiting, run by Mengchang Yang 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 3 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 27 Jul 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The incidence of PONV within 24 hours after each group's operation. (time frame: Day 1). 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 27 Jul 2023.