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

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ClinicalTrials.gov Identifier: NCT03391700
Recruitment Status : Unknown
Verified June 2018 by Jin-Young Hwang, SMG-SNU Boramae Medical Center.
Recruitment status was:  Recruiting
First Posted : January 5, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Study Description
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Brief Summary:
Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: Rocuronium(deep) Drug: Rocuronium(moderate) Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 14, 2018
Estimated Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Moderate muscle relaxation
Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.
 Drug: 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.
Experimental: Deep muscle relaxation
Rocuronium is administered to maintain deep relaxation during operation.
 Drug: Rocuronium(deep)
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).


Outcome Measures
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Primary Outcome Measures :
  1. Overall incidence of postoperative sore throat [ Time Frame: Within 24 hrs after operation ]
    The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period


Secondary Outcome Measures :
  1. The incidence of postoperative sore throat [ Time Frame: At 1,6, and 24 hrs after operation ]
    The presence of sore throat is assessed.

  2. The severity of postoperative sore throat [ Time Frame: At 1,6, and 24 hrs after operation ]
    The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]).

  3. Incidence and severity of postoperative hoarseness [ Time Frame: At 1,6, and 24 hrs 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. Postoperative analgesic consumption [ Time Frame: Within 24 hrs after operation ]
    The amount of patient-controlled analgesia and other analgesic medication used


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391700


Contacts
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Contact: Jee-Eun Chang, M.D 82-2-870-2517 sw411528@hanmail.net

Locations
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Korea, Republic of
Jee-Eun Chang Recruiting
Seoul, Korea, Republic of, 07061
Contact: Jee-Eun Chang, M.D.    +82-2-870-2517    sw411528@hanmail.net   
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jee-eun Chang, M.D SMG-SNU Boramae Medical Center
More Information
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Responsible Party: Jin-Young Hwang, associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03391700    
Other Study ID Numbers: 20170601/10-2017-4/071
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Young Hwang, SMG-SNU Boramae Medical Center:
muscle relaxant
Additional relevant MeSH terms:
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Pharyngitis
Hoarseness
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
 Respiration Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms, Respiratory
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs