Skip to main content
OpenTrials
Completed

NCT Number: NCT03397797

Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sore Throat Infections Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jee-Eun Chang

Seoul, 07061, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

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

Primary outcomes

  1. Overall cumulative incidence of postoperative sore throat

    Time frame: Within 24 hr evaluation period after operation

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

  2. Overall cumulative incidence of postoperative hoarseness

    Time frame: Within 24 hr evaluation period after operation

    The incidence sore throat is assessed by the degree of hoarseness

Secondary outcomes

  1. Incidence of postoperative sore throat

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

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

  2. Severity of postoperative sore throat

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

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

  3. Incidence and severity of postoperative hoarseness

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

    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).

  4. Post operative analgesic consumption

    Time frame: within 24 hrs after operation

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

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness in Patients Undergoing Spinal Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.