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Effect of remimazolam-based total intravenous anesthesia on postoperative sleep quality in patients undergoing laparoscopic colorectal cancer surgery: A randomized controlled study

Effect of remimazolam-based total intravenous anesthesia on postoperative sleep quality in patients undergoing laparoscopic colorectal cancer surgery: A randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111562
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-03
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Postoperative sleep disorders are manifested as reduced nighttime sleep duration, disordered sleep structure, abnormal circadian rhythm, etc.

Interventions

Sponsors

People's Hospital of Jianyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old; 2.Plan to undergo laparoscopic colorectal cancer surgery under general anesthesia; 3.ASA classification grade 2 - 3.

Exclusion criteria

Exclusion criteria: 1.The patient refused to sign the informed consent form; 2.The patient has had severe sleep disorders in the past month and needs to receive medical intervention (such as hypnotic drugs). 3.Allergy to study drugs such as remimazolam or sevoflurane; 4.Preoperative cognitive impairment or severe hearing impairment leads to inability to communicate; 5.History of neurological or psychiatric diseases, or long-term use of sedative or anti-anxiety drugs; 6.Severe renal insufficiency (requiring renal replacement therapy); 7.Liver function impairment (Child-Pugh class C); 8.Body Mass Index (BMI) > 35 kg/m^2; 9.Have sleep apnea syndrome or moderate to severe snoring.

Design outcomes

Primary

MeasureTime frame
The incidence of sleep disturbances 1 days after surgery;

Secondary

MeasureTime frame
Sleep quality score 30 days after surgery;The incidence of sleep disturbances 30 days after surgery;The Pittsburgh Sleep Quality Index (PSQI) score on the 1st day after surgery;Anxiety scores on the 1st, 2nd, and 3rd day after surgery;The incidence of resedation after extubation in PACU;Length of hospital stay after surgery;Pittsburgh Sleep Quality Index (PSQI) score 3 days after surgery;PACU length of stay;The number of times the analgesic pump is pressed and the proportion of rescue analgesia on the 1st, 2nd, and 3rd days after surgery;The incidence of intraoperative awareness;Time of postoperative extubation;The incidence of nausea and vomiting within 24 hours after surgery;The incidence of delirium during postoperative hospitalization;The incidence of bradycardia (HR < 50 beats per minute) 1 day after surgery;Sleep bracelet monitoring indicators on the 1st, 2nd, and 3rd day after surgery;The incidence of sleep disturbances 3 days after surgery;The resting VAS pain scores on the 1st, 2nd, and 3rd day after surgery;The incidence of postoperative hypoxemia (SpO2 < 92%) on the 1st day;

Countries

China

Contacts

Public ContactWenjie Mao

People's Hospital of Jianyang City

35917029@qq.com+86 15282219022

Outcome results

None listed

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