Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

NCT02256358 | Completed Results

• 1 other identifier: 2012-127
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Conditions

Psychomotor Agitation

Keywords

child, ketamine, midazolam

Outcome Measures

Primary Outcomes (1)

• Emergence Agitation

  The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.

  During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.

Drug: Midazolam

Ketamine

EXPERIMENTAL

Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.

Drug: Ketamine

Interventions

Midazolam DRUG

preoperatively injected intravenous 0.1 mg/kg midazolam

Midazolam

Ketamine DRUG

Preoperatively injected intravenous 1mg/kg ketamine

Also known as: Ketamine HCl

Ketamine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\<2hr)

You may not qualify if:

• children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

Sponsors & Collaborators

• Inje University: lead

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Midazolam; Ketamine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

We did not include a placebo group.

Results Point of Contact

• Title: Kihwa Lee
• Organization: Haeundae Paik Hospital, Inje University

tedy333@paik.ac.kr

82-51-797-0426

Study Officials

• Kihwa Lee, MD

  Haeundae paik hospital, inje university

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 20, 2014
• Results First Posted: October 9, 2014

Record last verified: 2014-10