Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

Sore Throat Clinical Trial

Official title:

Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391700
• Other study ID #: 20170601/10-2017-4/071
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 14, 2019

Study information

• Verified date: June 2018
• Source: SMG-SNU Boramae Medical Center
• Contact: Jee-Eun Chang, M.D
• Phone: 82-2-870-2517
• Email: sw411528[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Description:

In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: August 14, 2019
• Est. primary completion date: July 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria:

• Hoarseness and sore throat existed before surgery

• Upper respiratory infection

• Known or predicted difficult airway

• Liver, renal disease

• Requirement of postoperative ventilator care

• the operation within 2hrs

• Laparoscopic surgery

• Other positions except supine during surgery

Related Conditions & MeSH terms

• Hoarseness
• Pharyngitis
• Sore Throat

Intervention

Drug:
• Rocuronium(deep)
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).
• Rocuronium(moderate)
In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.

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 incidence of postoperative sore throat	The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period	Within 24 hrs after operation
Secondary	The incidence of postoperative sore throat	The presence of sore throat is assessed.	At 1,6, and 24 hrs after operation
Secondary	The severity of postoperative sore throat	The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]).	At 1,6, and 24 hrs 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 hrs after operation
Secondary	Postoperative analgesic consumption	The amount of patient-controlled analgesia and other analgesic medication used	Within 24 hrs after operation