NCT05556408

Brief 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. We conducted a prospective interventional study on the effect of succinylcholine on the barrier pressure (BrP) of the esophagogastric junction.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 23, 2022

Last Update Submit

September 23, 2022

Conditions

Keywords

lower esophageal sphincterintragastric pressuresuccinylcholine

Outcome Measures

Primary Outcomes (2)

  • 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.

    15 minutes

  • pressure of intragastric

    IGP was measured at 2 cm below the crural diaphragmatic component of the LES

    15 minutes

Study Arms (1)

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.

Drug: Succinylcholine

Interventions

1.5mg/kg was given intravenously

Also known as: propofol
High-Resolution Solid-State Manometry

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SuccinylcholinePropofol

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOnium CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

March 1, 2015

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share