Remifentanil Requirement for Acceptable Intubating Condition

NCT02655380 | Completed Phase 4

• 1 other identifier: MED-DRU-15-354
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubating Condition

Outcome Measures

Primary Outcomes (1)

• acceptability of intubation condition

  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. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

  during and after intubation, about 2 minute

Study Arms (2)

ketamine 1

EXPERIMENTAL

Anesthesia induction with ketamine 1 mg followed by remifentanil.

Drug: Ketamine 1; Drug: Remifentanil

ketamine 2

EXPERIMENTAL

Anesthesia induction with ketamine 2 mg followed by remifentanil.

Drug: Ketamine 2; Drug: Remifentanil

Interventions

Ketamine 1 DRUG

Anesthesia induction is performed with 1 mg ketamine.

ketamine 1

Ketamine 2 DRUG

Anesthesia induction is performed with 2 mg ketamine.

ketamine 2

Remifentanil DRUG

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

ketamine 1; ketamine 2

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yun jeong chae, Ph.D

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 14, 2016
• Study Start: June 19, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

KR (1)