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NCT Number: NCT07450495

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

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.

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Key information

Conditions

Chalazion Cysts Eye Diseases Eyelid Diseases Neoplasms

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Written informed consent obtained from parents or legal guardians

Exclusion criteria

  • ASA physical status II or higher
  • Known hepatic or renal dysfunction
  • Congenital heart disease
  • History of malignant hyperthermia
  • Known allergy to sevoflurane
  • History of asthma or severe respiratory disease
  • Upper respiratory tract infection within the past 4 weeks
  • Anticipated difficult airway
  • Refusal of participation by parents or legal guardians

Treatment and study plan

Sevoflurane

Drug

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

Other names: Sevorane,Sevorane,Ultane

Primary outcomes

  1. PAED score

    Time frame: Within 30 minutes after recovery

    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).

Secondary outcomes

  1. Induction time

    Time frame: Immediately after anesthesia induction

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

  2. Recovery time

    Time frame: Immediately after anesthesia discontinuation

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

  3. Minimum alveolar concentration (MAC)

    Time frame: Perioperatively

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

  4. Respiratory depression

    Time frame: Perioperatively

    Incidence of respiratory depression recorded during the perioperative period.

  5. Hypoxia

    Time frame: Perioperatively

    Incidence of hypoxia recorded during the perioperative period.

  6. Cough

    Time frame: Perioperatively

    Incidence of cough recorded during the perioperative period.

  7. Nausea and vomiting

    Time frame: Immediately after anesthesia until discharge

    Incidence of nausea and vomiting recorded during the postoperative recovery period.

Sponsors and collaborators

Lead sponsor

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Other

Registry information

Official study title

Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial

Acronym: SEVO-PED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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