Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

Pediatric Disorder Clinical Trial

Official title:

Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients Who Underwent Ophthalmic Surgery Under General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053489
• Other study ID #: 2023-09-09
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: 82-10-7641-1774
• Email: anekhy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Pediatric Disorder

Intervention

Other:
• general anesthesia with remimazolam
general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to extubation	Time to extubation after the end of general anesthesia	Immediate after the end of general anesthesia
Secondary	Time for post-anesthesia recovery	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.	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
Secondary	Postoperative pain	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').	Immediate after entering the PACU, 15 minutes after entering the PACU
Secondary	Incidence of emergence delirium	Emergence delirium measured after entering the PACU	Immediate after entering the PACU, 15 minutes after entering the PACU
Secondary	Adverse events and complications	Adverse events and complications that occur during anesthesia and recovery from anesthesia	during general anesthesia, and recovery after general anesthesia, up to 1 day