the Effect of Succinylcholine on Barrier PressurePhase 4NCT05556408
High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure
A Phase 4 study testing Succinylcholine in people with the Effect of Succinylcholine on Barrier Pressure, run by China-Japan Friendship Hospital.
Trial summary
The lower esophageal sphincter（LES）plays a key role in preventing regurgitation and aspiration. The pressure of LES partly comes from striated muscles derived from the crural portion of the diaphragm. The effect of succinylcholine on esophagogastric junction during anesthesia induction is not clear. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- the Effect of Succinylcholine on Barrier Pressure
- What is being tested?
- Succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Exclusion criteria：patients who classified as American Society of Anesthesiologists classification system (ASA) II were included. Patients were included in the study if they had on history of diabetes, pharynx and digestive diseases.
Exclusion criteria：currently pregnant or breastfeeding, a body mass index (BMI) over 30 kg/m2. All patients underwent preoperative preparation according to clinical routine and did not give preoperative drugs.
About this study
The lower esophageal sphincter（LES）plays a key role in preventing regurgitation and aspiration. The pressure of LES partly comes from striated muscles derived from the crural portion of the diaphragm. The effect of succinylcholine on esophagogastric junction during anesthesia induction is not clear. We conducted a prospective interventional study on the effect of succinylcholine on the barrier pressure (BrP) of the esophagogastric junction.
Read the detailed description
14 patients participated in the study. Propofol and succinylcholine were used for anesthesia induction. High-resolution solid-state manometry (HRM) was used to monitor the changes of the LES pressure and the intragastric pressure (IGP).The administration of propofol could significantly increase the LES pressure during end expiration and during inspiration. The application of succinylcholine had no effect on the LES pressure during end expiration, but significantly reduced the LES pressure during inspiration. Propofol had no effect on BrP. After the application of succinylcholine, BrP decreased significantly during inspiration.
Propofol significantly increased the LES pressure. Succinylcholine significantly reduced the pressure of LES and BrP during inspiration.
- Being tested
- Succinylcholine
- Keywords
- lower esophageal sphincter, intragastric pressure, succinylcholine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
Also called propofol
1.5mg/kg was given intravenously
| Study group | Role | What they receive |
|---|---|---|
| High-Resolution Solid-State Manometry | Other | Before catheterization, the patients were monitored by pulse oximetry, electrocardiogram, automatic noninvasive arterial blood pressure and bispectral index (BIS). Before the insertion of the manometric catheter an intravenous cannula was inserted. The manometric catheter was placed through the nose until the pressure from the lower esophageal sphincter to the stomach could be recorded. After confirming the position of the catheter, the catheter was taped to the nose. Receives: Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure of lower esophageal sphincter
On the isocontour plots, the esophageal sphincter can be located as abrupt transitions in the pressure pattern (Fig. 2). The proximal edge of the LES was defined by sudden transition to the intra-esophageal pressure, and the distal edge was defined by sudden transition to the IGP. The pressure of the LES measured during end expiration was defined as the pressure of intrinsic sphincter to avoid the influence from the rural component of the LES. The rural component of the LES was defined as the highest pressure point at the esophagogastric junction during inspiration.
Measured: 15 minutes
pressure of intragastric
IGP was measured at 2 cm below the crural diaphragmatic component of the LES
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Mar 2015
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of Succinylcholine on Barrier PressureStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanting Cao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556408
- Sponsor's protocol ID
- the Effect of Succinylcholine
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- 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 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure
- ClinicalTrials.gov ID
- NCT05556408
- Acronym / sponsor ID
- the Effect of Succinylcholine
- Keywords
- lower esophageal sphincter, intragastric pressure, succinylcholine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 27 Sep 2022 (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.
The lower esophageal sphincter（LES）plays a key role in preventing regurgitation and aspiration. The pressure of LES partly comes from striated muscles derived from the crural portion of the diaphragm. The effect of succinylcholine on esophagogastric junction during anesthesia induction is not clear. We conducted a prospective interventional study on the effect of succinylcholine on the barrier pressure (BrP) of the esophagogastric junction.
Detailed description
14 patients participated in the study. Propofol and succinylcholine were used for anesthesia induction. High-resolution solid-state manometry (HRM) was used to monitor the changes of the LES pressure and the intragastric pressure (IGP).The administration of propofol could significantly increase the LES pressure during end expiration and during inspiration. The application of succinylcholine had no effect on the LES pressure during end expiration, but significantly reduced the LES pressure during inspiration. Propofol had no effect on BrP. After the application of succinylcholine, BrP decreased significantly during inspiration.
Propofol significantly increased the LES pressure. Succinylcholine significantly reduced the pressure of LES and BrP during inspiration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Resolution Solid-State Manometry | Other | Drug: SuccinylcholineBefore catheterization, the patients were monitored by pulse oximetry, electrocardiogram, automatic noninvasive arterial blood pressure and bispectral index (BIS). Before the insertion of the manometric catheter an intravenous cannula was inserted. The manometric catheter was placed through the nose until the pressure from the lower esophageal sphincter to the stomach could be recorded. After confirming the position of the catheter, the catheter was taped to the nose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SuccinylcholineAlso: propofol1.5mg/kg was given intravenously | Drug | High-Resolution Solid-State Manometry |
Primary outcome
pressure of lower esophageal sphincter
Time frame: 15 minutes
On the isocontour plots, the esophageal sphincter can be located as abrupt transitions in the pressure pattern (Fig. 2). The proximal edge of the LES was defined by sudden transition to the intra-esophageal pressure, and the distal edge was defined by sudden transition to the IGP. The pressure of the LES measured during end expiration was defined as the pressure of intrinsic sphincter to avoid the influence from the rural component of the LES. The rural component of the LES was defined as the highest pressure point at the esophagogastric junction during inspiration.
pressure of intragastric
Time frame: 15 minutes
IGP was measured at 2 cm below the crural diaphragmatic component of the LES
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 27 Sep 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Succinylcholine in people with the Effect of Succinylcholine on Barrier Pressure, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
pressure of lower esophageal sphincter (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 Sep 2022.