High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure

September 23, 2022 updated by: Yanting Cao, China-Japan Friendship Hospital
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • propofol

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 30, 2015

Study Completion (Actual)

December 30, 2015

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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