Remifentanil Requirement for Acceptable Intubating Condition

Intubating Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655380
• Other study ID #: MED-DRU-15-354
• Status: Completed
• Phase: Phase 4
• Start date: June 19, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: January 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Intubating Condition

Intervention

Drug:
• Ketamine 1
Anesthesia induction is performed with 1 mg ketamine.
• Ketamine 2
Anesthesia induction is performed with 2 mg ketamine.
• Remifentanil
After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.

Locations

Country	Name	City	State
Korea, Republic of	Ajou universitiy school of medicine	Suwon-si	Gyeong-gi Do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; Laryngoscope easiness; Vocal cord position; Vocal cord movement; Movement of limb; Coughing	during and after intubation, about 2 minute