ClinicalTrials.gg
Status unknownNCT03391700Updated Jun 26, 2018

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

An interventional study of Rocuronium(deep) and Rocuronium(moderate) in Sore Throat, sponsored by SMG-SNU Boramae Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-06-26.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by SMG-SNU Boramae Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2017, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sore Throat

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Keywords

  • muscle relaxant
03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's planned enrollment of 206 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Requirement for mechanical ventilation under general anesthesia

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
206 participants (estimated)

Study arms

  • 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)

  • Experimental
    Deep muscle relaxation

    Rocuronium is administered to maintain deep relaxation during operation.

    Drug: Rocuronium(deep)

Interventions

  • In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).

  • 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.

06

What researchers measure

Primary outcomes

  1. Overall incidence of postoperative sore throat

    The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period

    Time frame: Within 24 hrs after operation

Secondary outcomes

  1. The incidence of postoperative sore throat

    The presence of sore throat is assessed.

    Time frame: At 1,6, and 24 hrs after operation

  2. 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 \[worst pain imaginable\]).

    Time frame: At 1,6, and 24 hrs after operation

  3. 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).

    Time frame: At 1,6, and 24 hrs after operation

  4. Postoperative analgesic consumption

    The amount of patient-controlled analgesia and other analgesic medication used

    Time frame: Within 24 hrs after operation

07

Study locations

1 of 1 sites recruiting
  • Jee-Eun Chang
    Seoul, 07061, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391700
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (associate professor, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Jan 5, 2018
Start date
Aug 1, 2017
Primary completion
Jul 14, 2018 (estimated)
Completion
Aug 14, 2019 (estimated)
Last update
Jun 26, 2018

Study contacts

Jee-Eun Chang, M.D
Contact
sw411528@hanmail.net
82-2-870-2517
Jee-eun Chang, M.D
principal investigator · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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