Effect of remazolam toluenesulfonate on postoperative emergence delirium in patients undergoing elective gastrointestinal cancer surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046788

Enrollment

Unknown

Registered

2021-05-28

Start date

2021-06-01

Completion date

Unknown

Last updated

2022-01-10

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

Conditions

Emergence delirium

Interventions

Remazolam toluene sulfonate group:Induction and maintenance of remazolam toluenesulfonate

Midazolam group:Midazolam and propofol induction, propofol maintenance

Propofol group:Induction and maintenance of propofol

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 65 to 85 years; 2.Perform elective gastrointestinal surgery; 3.The ASA score II or III; 4.Clearly understand and voluntarily participate in the study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.A history of cerebrovascular accidents; 2.A history of taking psychotropic drugs within six months before admission; 3.Suffering from mental disorders (schizophrenia or epilepsy, senile dementia, etc.); 4.Sinus bradycardia or atrioventricular block at above II degree; 5.Visual, auditory or language communication barriers; 6.Severe liver or kidney dysfunction; 7.Allergic to benzodiazepines or their components; 8.Plan to stay in ICU after operation; 9.The score of the Mini-Mental State Scale (MMSE) before operation cannot be matched and is lower than the minimum score of the corresponding education level (literacy <=17 points, primary school <=20 points, secondary school <=22 points, university <=23 points); 10.Other circumstances that the investigator considers inappropriate to participate in this trial.

Design outcomes

Primary

Measure	Time frame
the incidence of emergence delirium;regional cerebral oximetry;	—

Secondary

Measure	Time frame
hemodynamic index;postoperative complication;anesthesia recovery time;extubation time;brainwave dual frequency index >60/70/80 time;the time between cessation of anesthetic use and Aldrete score >9;incidence of postoperative delirium;degree of reduction in the short mental state scale;visual analog pain score;length of stay and cost of stay;total opioid use;intraoperative awareness of incidence;hemorrhage during operation;postoperative renal function;postoperative liver function;	—

Measure

Time frame

hemodynamic index;postoperative complication;anesthesia recovery time;extubation time;brainwave dual frequency index >60/70/80 time;the time between cessation of anesthetic use and Aldrete score >9;incidence of postoperative delirium;degree of reduction in the short mental state scale;visual analog pain score;length of stay and cost of stay;total opioid use;intraoperative awareness of incidence;hemorrhage during operation;postoperative renal function;postoperative liver function;

—

Countries

China

Contacts

Public ContactZhang Xiaobao

The First People's Hospital of Lianyungang

hotdog100@163.com+86 18961322507

Outcome results

None listed

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