The ability of IOC2 index to predict hemodynamic fluctuations in children undergoing general anesthesia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078662

Enrollment

Unknown

Registered

2023-12-14

Start date

2023-12-15

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemodynamic fluctuations

Interventions

Intervention Group:Adjusting the intraoperative analgesia depth at the guidance of IOC2

Control Group:Adjusting the intraoperative analgesia depth at the discretion of anesthesiologist

Eligibility

Sex/Gender

All

Age

6 Months to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children between 6 months and 12 years old; 2. American Society of Anesthesiologists (ASA) Grade I or II; 3. Elective general surgery or urological surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Have a brain disorder (epilepsy, autism, history of cognitive impairment); 2. Patients with arrhythmia; 3. Patients with a history of chronic pain before surgery; 4. Ketamine used for anesthesia.

Design outcomes

Primary

Measure	Time frame
The ability of IOC2 index to predict hemodynamic fluctuations during intraoperative nociceptive stimuli in pediatric patients;	—

Secondary

Measure	Time frame
The ability of IOC1 index to predict hemodynamic fluctuations during intraoperative nociceptive stimuli in pediatric patients;Compare the dosage of remifentanil during surgery between the two groups guided by IOC2 and empirical medication;Whether IOC1 and IOC2 can reflect changes in hemodynamic fluctuations;;Whether IOC1 and IOC2 can sense nociceptive stimuli;;Compare the number of intraoperative hemodynamic fluctuations during IOC2 instruction and empirical treatment.;Compare the Pain scores at 1h, 2h and 6h after surgery between the IOC2 guidance and empirical treatment groups.;	—

Measure

Time frame

The ability of IOC1 index to predict hemodynamic fluctuations during intraoperative nociceptive stimuli in pediatric patients;Compare the dosage of remifentanil during surgery between the two groups guided by IOC2 and empirical medication;Whether IOC1 and IOC2 can reflect changes in hemodynamic fluctuations;;Whether IOC1 and IOC2 can sense nociceptive stimuli;;Compare the number of intraoperative hemodynamic fluctuations during IOC2 instruction and empirical treatment.;Compare the Pain scores at 1h, 2h and 6h after surgery between the IOC2 guidance and empirical treatment groups.;

—

Countries

China

Contacts

Public ContactYu Bin

Peking University First Hospital Ningxia Women's and Children's Hospital

1225299409@qq.com+86 181 6157 3083

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026