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Effect of intraoperative infusion of Remimazolam on sleep disturbance in elderly female patients after general anesthesia

Effect of intraoperative infusion of Remimazolam on sleep disturbance in elderly female patients after general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081855
Enrollment
Unknown
Registered
2024-03-14
Start date
2024-03-14
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Postoperative Sleep Disturbance

Interventions

Remimazolam Group (R Group):Induction anesthesia with remimazolam ( -1) and sufentanil (0.3-0.5ug.kg 1) for sedation and analgesia. Inhalation of Desflurane 0.3 MAC in combination with an intravenous
Propofol Group (P Group):Propofol ( -1) was used to induce anesthesia and sufentanil (0.3-0.5ug.kg 1) was used for sedation and analgesia. Inhalation of 0.3 Mac desflurane combined with intravenous in

Sponsors

the third affiliated hospital of Sun Yat-Sen university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age =65 years; (2) ASA = III; (3) Patients scheduled for elective gynecological laparoscopy under general anesthesia with tracheal intubation; (4) Agree to participate in the clinical trial and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with cognitive impairment or other inability to communicate to complete the scale assessment; (2) BMI above 30; (3) Preoperative Pittsburgh sleep quality index (PSQI) above 7; (4) Recent history of substance abuse; (5) Contraindications or allergies to remimazolam; (6) Patients with a history of mental illness or being treated with psychotropic drugs; (7) Other conditions considered unsuitable for inclusion by the investigators (specific reasons should be noted) .

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disturbance on the first postoperative day;Incidence of sleep disturbance on the third postoperative day;

Secondary

MeasureTime frame
HADS score on the first postoperative day;HADS score on the third postoperative day;The rest and movement pain scores on the first postoperative day;The rest and movement pain scores on the third postoperative day;Operation Time;Anesthesia time;Extubation time;Intraoperative and postoperative complications;Intraoperative remifentanil consumption;PACU dwell time;Use of painkillers after operation;Intraoperative fluid infusion volume;Intraoperative bleeding volume;Urine output;

Countries

China

Contacts

Public ContactXiang Li

the third affiliated hospital of Sun Yat-Sen university

lixiang27@mail.sysu.edu.cn+86 156 0239 1780

Outcome results

None listed

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