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

NCT01680471 | Completed DMC

• 1 other identifier: ECho2012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Anesthesia Morbidity; Delirium on Emergence

Keywords

emergence agitation; midazolam; sevoflurane; strabismus

Outcome Measures

Primary Outcomes (1)

• Time of emergence

  The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.

  within the first 1hour after end of surgery

Secondary Outcomes (1)

• Incidence of emergency agitation

  From just after extubation until the discharge of PACU, assessed up to 1 hour

Study Arms (3)

Midazolam 0.03mg/kg

EXPERIMENTAL

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

Drug: Midazolam 0.03mg/kg

Midazolam 0.05mg/kg

EXPERIMENTAL

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

Drug: Midazolam 0.05mg/kg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Midazolam 0.03mg/kg 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.

Also known as: MIDAZOLAM BUKWANG INJ 5mg/5ml

Midazolam 0.03mg/kg

Midazolam 0.05mg/kg 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.

Also known as: MIDAZOLAM BUKWANG INJ 5mg/5ml

Midazolam 0.05mg/kg

Placebo 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.

Also known as: NORMAL SALINE INJ(Sodium chloride 9g/1000mL)

Placebo

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

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

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium; Strabismus

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eun Jung Cho, Resident

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

  PRINCIPAL INVESTIGATOR

• S.Z. Yoon, Professor

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

  STUDY DIRECTOR

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: Anesthesiology and Pain Medicine Department

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

KR (1)