Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02256358
• Collaborator: (none)
• Enrollment: 68
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psychomotor Agitation	Drug: Midazolam; Drug: Ketamine	N/A

Detailed Description

Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Midazolam Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.	Drug: Midazolam; preoperatively injected intravenous 0.1 mg/kg midazolam
Experimental: Ketamine Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.	Drug: Ketamine; Preoperatively injected intravenous 1mg/kg ketamine; Other Names: Ketamine HCl

Outcome Measures

Primary Outcome Measures

1. Emergence Agitation [During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Inje University

Investigators

• Study Chair: Kihwa Lee, MD, Haeundae paik hospital, inje university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ki Hwa Lee, Assistant professor, Inje University
• ClinicalTrials.gov Identifier: NCT02256358
• Other Study ID Numbers: 2012-127
• First Posted: Oct 3, 2014
• Last Update Posted: Oct 20, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Ki Hwa Lee, Assistant professor, Inje University: child, ketamine, midazolam
• Additional relevant MeSH terms: Psychomotor Agitation; Emergence Delirium; Midazolam; Ketamine

Study Results

Participant Flow

Arm/Group Title	Midazolam	Ketamine
Arm/Group Description	Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam	Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
Period Title: Overall Study
STARTED	34	34
COMPLETED	34	33
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Midazolam	Ketamine	Total
Arm/Group Description	Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam	Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine	Total of all reporting groups
Overall Participants	34	33	67
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	4.15 (1.40)	4.21 (1.32)	4.18 (1.35)
Sex: Female, Male (Count of Participants)
Female	18 52.9%	17 51.5%	35 52.2%
Male	16 47.1%	16 48.5%	32 47.8%

Outcome Measures

1. Primary Outcome

Title	Emergence Agitation
Description	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.
Time Frame	During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Midazolam	Ketamine
Arm/Group Description	Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam	Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
Measure Participants	34	33
Number [participants]	6 17.6%	0 0%

Adverse Events

Time Frame	1 day
Adverse Event Reporting Description	Recording of complications at 5 minutes intervals during 30 minutes after operation
Arm/Group Title	Midazolam		Ketamine
Arm/Group Description	Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam		Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
All Cause Mortality
	Midazolam		Ketamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Midazolam		Ketamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Midazolam		Ketamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)

Limitations/Caveats

We did not include a placebo group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.