Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

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

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

Study Overview

• Status: Completed
• Conditions: Sore Throat
• Intervention / Treatment: Drug: Rocuronium

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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07061
    • Jee-Eun Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective lumbar spinal surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with muscle relaxant; Rocuronium is used during the operation to maintain moderate relaxation.	Drug: Rocuronium; In the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction.
Group without muscle relaxant; Rocuronium is not used during the operation for the eletrophysiological monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cumulative incidence of postoperative sore throat	The incidence sore throat is assessed by the presence of sore throat	Within 24 hr evaluation period after operation
Overall cumulative incidence of postoperative hoarseness	The incidence sore throat is assessed by the degree of hoarseness	Within 24 hr evaluation period after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative sore throat	The incidence of sore throat is assessed by the presence of sore throat.	At 1,6, and 24 hr after operation
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).	At 1,6, and 24 hr after operation
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).	At 1,6, and 24 hr after operation
Post operative analgesic consumption	the amount of patient-controlled analgesia and other analgesic medication consumed	within 24 hrs after operation

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Jin-Yong Hwang, M.D.,Ph. D., SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 28, 2019
• Study Completion (Actual): November 29, 2019

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: muscle relaxant
• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Pharyngitis; Hoarseness; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 20170605/10-2017-6/063

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