The Effect of Fosaprepitant on Postoperative Delirium and Sleep Quality in Elderly Gynecological Laparoscopic Surgery Patients: A Prospective Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088071

Enrollment

Unknown

Registered

2024-08-09

Start date

2024-08-10

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Postoperative Cognitive Dysfunction And Postoperative Sleep Disturbance

Interventions

Fosaprepitant Group:Intravenous infusion of 150 mg fosaprepitant for injection dissolved in 150 ml 0.9% sodium chloride injection before anesthesia induction

Placebo Group:Intravenous infusion of 150 ml 0.9% sodium chloride injection before anesthesia induction

Eligibility

Sex/Gender

All

Age

65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (a) Participants undergoing elective gynecological laparoscopic surgery; (b) Participants aged 65 years or older; (c) Participants classified as American Society of Anesthesiologists (ASA) Physical Status I-III; (d) Participants with clear consciousness and normal communication ability.

Exclusion criteria

Exclusion criteria: (a) Adrenal gland diseases; (b) Severe neuropsychiatric disorders and significant dysfunctions of the heart, lungs, liver, and kidneys; (c) History of alcohol or drug abuse; (d) History of cerebral infarction or cerebral hemorrhage in the past six months; (e) Pittsburgh Sleep Quality Index (PSQI) score = 7 within one month before surgery; (f) Long-term use of sedative or antidepressant medications; (g) Patients with central nervous system diseases (e.g., dementia or memory decline) with a Mini-Mental State Examination (MMSE) score = 23.

Design outcomes

Primary

Measure	Time frame
Postoperative Delirium, POD;Postoperative Sleep Quality, PSQ;	—

Secondary

Measure	Time frame
Surgical duration;Anesthesia duration;Intraoperative blood loss;Intraoperative fluid replacement volume;Intraoperative urine output;Types and dosages of anesthetic drugs;Types and dosages of vasoactive drugs;The average recovery time;Ramsay Sedation Rating;Postoperative VAS pain score;Types and dosages of postoperative analgesics used;BIS values before and after infusion of Fosapritan;	—

Countries

China

Contacts

Public ContactMingyue Ge

Obstetrics and Gynecology Hospital of Fudan University

shz39931705@163.com+86 152 2102 1593

Outcome results

None listed

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