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Effect of remimazolam total intravenous general anesthesia on emergence agitation in children undergoing laparoscopic surgery

Effect of remimazolam total intravenous general anesthesia on emergence agitation in children undergoing laparoscopic surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073024
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

emergence agitation

Interventions

group R:remimazolam total intravenous general anesthesia
group P:propofol total intravenous general anesthesia
group S:sevoflurane inhalation anesthesia

Sponsors

Affiliated Boai Hospital of Zhongshan, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.1 to 7 years; 2. Body weight ranged from 4 to 25 kg; 3.ASA(American society of anesthesiologists)?~?; 4. Mallampati grade?~?.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of a recent upper respiratory infection; 2. Those who are allergic to drugs; 3. Obvious cardiopulmonary dysfunction; 4. Those who have a history of neurological and psychiatric disorders; 5. Sedative or analgesic drugs were used within 24 hours before surgery; 6. Those who have a family history of malignant hyperthermia.

Design outcomes

Primary

MeasureTime frame
Total incidence of emergence agitation in children;Incidence of severe emergence agitation;

Secondary

MeasureTime frame
duration of surgery ;duration of anesthesia;extubation time;MAP and heart rate at admission, tracheal intubation, Trocar puncture, and extubation;Incidence of injection pain during induction of anesthesia;MOAA/S score for immediate sedation after tracheal extubation;The FLACC pain score were recorded at the time of discharge from PACU;The agitation-sedation RASS score were recorded at the time of discharge from PACU;The delirium PAED score were recorded at the time of discharge from PACU;FLACC pain score at 24 hours after surgery;Incidence of adverse events: laryngspasm, tongue suffix, bucking, hypoxemia, PONV, abdominal distention;

Countries

China

Contacts

Public ContactZeng Wei

Department of Anesthesiology.Affiliated Boai Hospital of Zhongshan, Southern Medical University

1796830968@qq.com+86 137 9073 2991

Outcome results

None listed

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