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

NCT ID: NCT01680471

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-11-30

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.

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.

Conditions

Child; Anesthesia Morbidity; Delirium on Emergence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Midazolam 0.03mg/kg

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

Group Type: EXPERIMENTAL

Midazolam 0.03mg/kg

Intervention Type: DRUG

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.

Midazolam 0.05mg/kg

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

Group Type: EXPERIMENTAL

Midazolam 0.05mg/kg

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MIDAZOLAM BUKWANG INJ 5mg/5ml; MIDAZOLAM BUKWANG INJ 5mg/5ml; NORMAL SALINE INJ(Sodium chloride 9g/1000mL)

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eun Jung Cho

Anesthesiology and Pain Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun Jung Cho, Resident

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital

S.Z. Yoon, Professor

Role: STUDY_DIRECTOR

Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital

Locations

Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ECho2012

Identifier Type: -

Identifier Source: org_study_id