- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556408
High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: High-Resolution Solid-State Manometry
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.
|
1.5mg/kg was given intravenously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15 minutes
|
|
pressure of intragastric
Time Frame: 15 minutes
|
IGP was measured at 2 cm below the crural diaphragmatic component of the LES
|
15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- the Effect of Succinylcholine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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