A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01680471

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

22.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%.

The purpose of this study is to verify that the prophylactic use of midazolam, which is a GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces the incidence of emergence agitation after sevoflurane anesthesia in children. Simultaneously, this study aims to find out the proper dose of midazolam with minimum disturbance to patient's emergence time.

Condition or Disease	Intervention/Treatment	Phase
Child Anesthesia Morbidity Delirium on Emergence	Drug: Midazolam 0.03mg/kg Drug: Midazolam 0.05mg/kg Drug: Placebo	N/A

Detailed Description

Sevoflurane is associated with a high incidence of emergence agitation in children. The etiology of emergence agitation is unclear. Some studies proposed that emergence agitation was related to a variable rate of neurologic recovery rate in different brain areas and immaturity of neurons. Inhalation anesthetics have been known to exert transient paradoxical excitatory effects in both animals and human patients, especially in children. The gamma(γ)-aminobutyric acid (GABA)A receptor is the target depressant effect site of most anesthetic drugs including sevoflurane. Midazolam acts on the benzodiazepine binding site of GABAA receptors and results in inhibitory effects on the central nervous system. The effect of midazolam premedication, as well as midazolam administration at the end of surgery, on suppressing emergence agitation has been studied. However, the effect of midazolam on emergence agitation is still controversial. This study aims to figure out the effect of midazolam at the end of surgery on emergence agitation during the recovery period, and find out the proper dose of midazolam with minimum disturbance to patient's emergence time.

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Midazolam 0.03mg/kg This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.	Drug: Midazolam 0.03mg/kg This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. Other Names: MIDAZOLAM BUKWANG INJ 5mg/5ml
Experimental: Midazolam 0.05mg/kg This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.	Drug: Midazolam 0.05mg/kg This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. Other Names: MIDAZOLAM BUKWANG INJ 5mg/5ml
Placebo Comparator: Placebo This group will be injected intravenous normal saline five minutes before the end of surgery.	Drug: Placebo This group will be injected intravenous normal saline five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. Other Names: NORMAL SALINE INJ(Sodium chloride 9g/1000mL)

Arm

Intervention/Treatment

Experimental: Midazolam 0.03mg/kg

This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.

Drug: Midazolam 0.03mg/kg

This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.

Other Names:

MIDAZOLAM BUKWANG INJ 5mg/5ml

Experimental: Midazolam 0.05mg/kg

This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.

Drug: Midazolam 0.05mg/kg

This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.

Other Names:

MIDAZOLAM BUKWANG INJ 5mg/5ml

Placebo Comparator: Placebo

This group will be injected intravenous normal saline five minutes before the end of surgery.

Drug: Placebo

This group will be injected intravenous normal saline five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.

Other Names:

NORMAL SALINE INJ(Sodium chloride 9g/1000mL)

Outcome Measures

Primary Outcome Measures

Time of emergence [within the first 1hour after end of surgery]
The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.

Secondary Outcome Measures

Incidence of emergency agitation [From just after extubation until the discharge of PACU, assessed up to 1 hour]
Agitation is assessed immediately after extubation, and continuously thereafter until participants are calm. Emergence agitation is evaluated using the four-point emergence scale and the pediatric anesthesia emergence delirium scale. The highest scores are recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists physical status I and II patients
Aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia
Willing to be assigned to any of the study intervention groups

Exclusion Criteria:

Refusal by parents
Neurological disease
Developmental delay
History of any previous surgery
Airway disease
American Society of Anesthesiologists physical status score of III or IV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital	Seoul		Korea, Republic of	136-705

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Principal Investigator: Eun Jung Cho, Resident, Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
Study Director: S.Z. Yoon, Professor, Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital