Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397797
• Other study ID #: 20170605/10-2017-6/063
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: November 29, 2019

Study information

• Verified date: December 2019
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 29, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hoarseness
• Pharyngitis
• Sore Throat

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jee-Eun Chang	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Post operative analgesic consumption	the amount of patient-controlled analgesia and other analgesic medication consumed	within 24 hrs after operation