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OpenTrials
Completed

NCT Number: NCT02655380

Remifentanil Requirement for Acceptable Intubating Condition

Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.

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Key information

Conditions

Intubating Condition

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-II
  • Undergoing general anesthesia with endotracheal tube

Exclusion criteria

  • Anticipated difficult airway
  • Patient with upper respiratory infection within 14 days
  • Asthma

Treatment and study plan

Ketamine 1

Drug

Anesthesia induction is performed with 1 mg ketamine.

Ketamine 2

Drug

Anesthesia induction is performed with 2 mg ketamine.

Remifentanil

Drug

After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.

Primary outcomes

  1. acceptability of intubation condition

    Time frame: during and after intubation, about 2 minute

    For assessment of intubation condition, 5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition.

    • Laryngoscope easiness
    • Vocal cord position
    • Vocal cord movement
    • Movement of limb
    • Coughing

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2016
Registry last updated
Jan 10, 2019

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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