search
Back to results

A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block

Primary Purpose

Emergence Agitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low dose sevoflurane group
high dose sevoflurane group
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation focused on measuring emergence agitation, sevoflurane, children

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1

Exclusion Criteria:

  • Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    low volume volatile anesthetics

    high volume volatile anesthetics

    Arm Description

    1.0 % sevoflurane sedation via face mask , low dose sevoflurane group

    2.5 % sevoflurane sedation via face mask, high dose sevoflurane group

    Outcomes

    Primary Outcome Measures

    postoperative agitation score
    Four-point agitation scale
    postoperative agitation score
    Four-point agitation scale
    postoperative agitation score
    Pediatric Anesthesia Emergence Delirium (PAED) scale
    postoperative agitation score
    Pediatric Anesthesia Emergence Delirium (PAED) scale

    Secondary Outcome Measures

    Full Information

    First Posted
    April 21, 2017
    Last Updated
    April 28, 2017
    Sponsor
    Yeungnam University College of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03134547
    Brief Title
    A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
    Official Title
    A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yeungnam University College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was performed to compare the incidence of EA between two dose of sevoflurane for sedation with caudal block in children, and intended to find the optimal dose for prevention of sevoflurane induced emergence agitation
    Detailed Description
    After approval Institutional Review Board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. By a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (Group LS) or the high dose (2.5%) end tidal concentration of sevoflurane group (Group HS). The patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. Then the patients were into the operating room, applied electrocardiography (ECG), pulse oximetry, and noninvasive blood pressure. Respiratory rate and end tidal carbon dioxide (CO2) were monitored via face mask. After baseline vital signs were monitored, the patient was posed in lateral Sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 G needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. All of these procedures were performed by one skilled anesthesiologist who blinded about the study group. After caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. If oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. If analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly. In the postanesthetic care unit (PACU), the investigators observed EA episodes at 5 and 30 min after PACU arrival using Four-point agitation scale and Pediatric Anesthesia Emergence Delirium (PAED) scale, and if a total score of PAED scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. EA was considered as an Four-point agitation scale > 3 or PAED scale > 10.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emergence Agitation
    Keywords
    emergence agitation, sevoflurane, children

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    low volume volatile anesthetics
    Arm Type
    Active Comparator
    Arm Description
    1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
    Arm Title
    high volume volatile anesthetics
    Arm Type
    Active Comparator
    Arm Description
    2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
    Intervention Type
    Drug
    Intervention Name(s)
    low dose sevoflurane group
    Other Intervention Name(s)
    1.0 %sevoflurane
    Intervention Description
    low volume volatile anesthetics (1.0%)
    Intervention Type
    Drug
    Intervention Name(s)
    high dose sevoflurane group
    Other Intervention Name(s)
    2.5% sevoflurane
    Intervention Description
    high volume volatile anesthetics (2.5%)
    Primary Outcome Measure Information:
    Title
    postoperative agitation score
    Description
    Four-point agitation scale
    Time Frame
    5 minutes in the recovery room
    Title
    postoperative agitation score
    Description
    Four-point agitation scale
    Time Frame
    30 minutes in the recovery room
    Title
    postoperative agitation score
    Description
    Pediatric Anesthesia Emergence Delirium (PAED) scale
    Time Frame
    5 minutes in the recovery room
    Title
    postoperative agitation score
    Description
    Pediatric Anesthesia Emergence Delirium (PAED) scale
    Time Frame
    30 minutes in the recovery room

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1 Exclusion Criteria: Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eun kyung Choi, MD,PhD
    Organizational Affiliation
    Yeungnam University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    15114210
    Citation
    Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
    Results Reference
    result
    PubMed Identifier
    9416712
    Citation
    Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
    Results Reference
    result

    Learn more about this trial

    A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block

    We'll reach out to this number within 24 hrs