Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery

ConditionChalazion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorJoint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

About this trial

This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 1 to 6 years (12-72 months)

Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia

American Society of Anesthesiologists (ASA) physical status I

Assessed as suitable for inhalation anesthesia by anesthesiologists

Disqualifiers

ASA physical status II or higher

Known hepatic or renal dysfunction

Congenital heart disease

History of malignant hyperthermia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sevoflurane

    Drug

    Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Sevoflurane 8% GroupActive comparator 1 intervention
Group B: Sevoflurane 6% GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PAED score

Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).

Time frame
Within 30 minutes after recovery

Secondary outcomes

1

Induction time

Time from face mask placement to loss of eyelash reflex, measured in seconds.

Time frame
Immediately after anesthesia induction
2

Recovery time

Time from discontinuation of sevoflurane to full recovery of consciousness, measured in minutes.

Time frame
Immediately after anesthesia discontinuation
3

Minimum alveolar concentration (MAC)

Minimum alveolar concentration (MAC) values recorded during anesthesia maintenance.

Time frame
Perioperatively
4

Respiratory depression

Incidence of respiratory depression recorded during the perioperative period.

Time frame
Perioperatively

Other outcomes

Sponsors and contacts

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