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CompletedNCT03397797Updated Dec 20, 2019

Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

An observational study in Sore Throat, sponsored by SMG-SNU Boramae Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-12-20.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by SMG-SNU Boramae Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
117
Ages
20 Years and older
Sex
All
01

Study summary

Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.

Read the detailed description

The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.

02

Conditions studied

  • Sore Throat

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Keywords

  • muscle relaxant
03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 117 is below the median of 289 across 33 observational studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients scheduled for elective lumbar spinal surgery

Eligibility criteria

Inclusion criteria

  • patients scheduled to undergo elective lumbar spinal surgery Exclusion criteria
  • known or predicted difficult airway
  • neuromuscular diseases
  • hepatic or renal dysfunction
  • diseases or anatomical abnormalities in the neck, larynx, or pharynx
  • requirement for postoperative mechanical ventilation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
117 participants (actual)
Patient registry
No

Groups and cohorts

  • Group with muscle relaxant

    Rocuronium is used during the operation to maintain moderate relaxation.

    Drug: Rocuronium

  • Group without muscle relaxant

    Rocuronium is not used during the operation for the eletrophysiological monitoring.

Interventions

  • In the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction.

06

What researchers measure

Primary outcomes

  1. Overall cumulative incidence of postoperative sore throat

    The incidence sore throat is assessed by the presence of sore throat

    Time frame: Within 24 hr evaluation period after operation

  2. Overall cumulative incidence of postoperative hoarseness

    The incidence sore throat is assessed by the degree of hoarseness

    Time frame: Within 24 hr evaluation period after operation

Secondary outcomes

  1. Incidence of postoperative sore throat

    The incidence of sore throat is assessed by the presence of sore throat.

    Time frame: At 1,6, and 24 hr after operation

  2. Severity of postoperative sore throat

    A 0-100 mm NRS is used to evaluate the severity of sore throat (0, no pain; 100, worst pain imaginable).

    Time frame: At 1,6, and 24 hr after operation

  3. Incidence and severity of postoperative hoarseness

    Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia).

    Time frame: At 1,6, and 24 hr after operation

  4. Post operative analgesic consumption

    the amount of patient-controlled analgesia and other analgesic medication consumed

    Time frame: within 24 hrs after operation

07

Study locations

1 site
  • Jee-Eun Chang
    Seoul, 07061, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03397797
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (associate professor, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Jan 12, 2018
Start date
Sep 1, 2017
Primary completion
Nov 28, 2019
Completion
Nov 29, 2019
Last update
Dec 20, 2019

Study contacts

Jin-Yong Hwang, M.D.,Ph. D.
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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