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Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT06053489
Recruitment Status : Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Kim Hee Young, Pusan National University Yangsan Hospital

Study Description
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Brief Summary:
The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.

Condition or disease Intervention/treatment
Ophthalmic Abnormalities Pediatric Disorder Other: general anesthesia with remimazolam

Detailed Description:
  • The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. It has the advantage of being able to induce anesthesia without securing an intravenous route and causing less irritation to the airway. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Emergence agitation can cause physical damage to the patient, workload in the recovery room, and dissatisfaction of the caregiver.
  • Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine drug used for inducing and maintaining general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it has the advantage of being metabolized quickly by enzymes in the liver compared to propofol, has a short context-sensitive half-life of 7.5 minutes, and can be reversed with flumazenil. Therefore, during general anesthesia using remimazolam, the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation.
  • However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients and its effect on endotracheal extubation time after anesthesia in operating room, emergence agitation, pain, and discharge time in the postanesthesia care unit (PACU).
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia
Estimated Study Start Date : June 30, 2024
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
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Intervention Details:
  • Other: general anesthesia with remimazolam
    general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery

Outcome Measures
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Primary Outcome Measures :
  1. Time to extubation [ Time Frame: Immediate after the end of general anesthesia ]
    Time to extubation after the end of general anesthesia


Secondary Outcome Measures :
  1. Time for post-anesthesia recovery [ Time Frame: From the time of immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more, assessed up to 4 hours ]
    Time taken until the patient can leave the PACU. The post-anesthesia recovery score (modified Aldrete score) is used for assessment of patient's activity, respiration, blood pressure, consciousness, and peripheral oxygen saturation. A score 9 points or more is required for discharge from the PACU.

  2. Postoperative pain [ Time Frame: Immediate after entering the PACU, 15 minutes after entering the PACU ]
    Visual analog scale (VAS) is going to be measured after entering the PACU. The VAS is a validated, subjective measure for acute and chronic pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  3. Incidence of emergence delirium [ Time Frame: Immediate after entering the PACU, 15 minutes after entering the PACU ]
    Emergence delirium measured after entering the PACU

  4. Adverse events and complications [ Time Frame: during general anesthesia, and recovery after general anesthesia, up to 1 day ]
    Adverse events and complications that occur during anesthesia and recovery from anesthesia


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
Criteria

Inclusion Criteria:

  • Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
  • When anesthesia was induced and maintained with remimazolam, or anesthesia was induced with propofol and maintained with sevoflurane.

Exclusion Criteria:

- none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053489


Contacts
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Contact: Hee Young Kim, MD, PhD 82-10-7641-1774 anekhy@gmail.com
Contact: Hee Young Kim, MD, PhD 82-10-7641-1774 yuvi1981@naver.com

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Hee Young Kim, MD, PhD Pusan National University Yangsan Hospital, Yangsan, South Korea
More Information
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Responsible Party: Kim Hee Young, Assistant professor for fund, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT06053489    
Other Study ID Numbers: 2023-09-09
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs