Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

NCT03397797 | Completed DMC

• 1 other identifier: 20170605/10-2017-6/063
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sore Throat

Keywords

muscle relaxant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of postoperative sore throat

  At 1,6, and 24 hr after operation

• Severity of postoperative sore throat

  At 1,6, and 24 hr after operation

• Incidence and severity of postoperative hoarseness

  At 1,6, and 24 hr after operation

• Post operative analgesic consumption

  within 24 hrs after operation

Study Arms (2)

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

Rocuronium DRUG

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

Group with muscle relaxant

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective lumbar spinal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

Jee-Eun Chang

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Pharyngitis; Muscle Hypotonia

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jin-Yong Hwang, M.D.,Ph. D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: January 12, 2018
• Study Start: September 1, 2017
• Primary Completion: November 28, 2019
• Study Completion: November 29, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)