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Completed

NCT Number: NCT03173339

Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.

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Key information

Conditions

Hip Arthroplasty Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University

Daegu, Non-US/Canada, 137-040, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

Exclusion criteria

  • Difficult airway
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Asthma
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Pregnancy
  • Allergy to remifentanil
  • Friable teeth
  • History of head and neck surgery
  • Multiple intubation attempts
  • Regional anesthetic agents
  • Gastric tube
  • Dexamethasone

Treatment and study plan

Endotracheal intubation using laryngoscope

Procedure

Endotracheal intubation was done using laryngoscope for general anesthesia.

High remifentanil

Drug

Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.

Low remifentanil

Drug

Remifentanil was administered as 0.1 mcg/kg/min.

High sevoflurane

Drug

Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.

Low sevoflurane

Drug

Sevoflurane was administered as 0.5 MAC.

Primary outcomes

  1. Number of participants with sore throat

    Time frame: At 24 hr

Secondary outcomes

  1. Number of participants with sore throat

    Time frame: At 0, 2, 4 and 24 hr

  2. Number of participants with hoarseness

    Time frame: At 0, 2, 4 and 24 hr

  3. Number of participants with cough

    Time frame: At 0, 2, 4 and 24 hr

  4. Number of participants with nausea

    Time frame: At 0, 2, 4 and 24 hr

  5. Number of participants with vomiting

    Time frame: At 0, 2, 4 and 24 hr

  6. Number of participants with additional pain medication

    Time frame: At 0, 2, 4 and 24 hr

  7. Visual analogue scale of postoperative pain

    Time frame: At 0, 2, 4 and 24 hr

  8. Number of participants with shivering

    Time frame: At 0, 2, 4 and 24 hr

  9. Requirements of analgesics

    Time frame: At 0, 2, 4 and 24 hr

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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