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The effect of remimazolam mesylate versus propofol on postoperative fatigue syndrome in patients with laparoscopic colorectal cancer: A randomized controlled trial

The effect of remimazolam mesylate versus propofol on postoperative fatigue syndrome in patients with laparoscopic colorectal cancer: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121258
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Colorectal Cance

Interventions

Remimazolam Group:Anesthesia induction: intravenous administration of remimazolam tosylate (0.2-0.3 mg/kg), sufentanil (0.5 ug/kg), and rocuronium (0.6 mg/kg)
anesthesia maintenance: infusion of remimazolam (0.3-1.0 mg/kg/h) combined with 1% sevoflurane inhalation, plus continuous intravenous infusion of remifentanil (8-15 ug/kg/h)
Propofol Group:Anesthesia induction: intravenous administration of propofol (1.0-1.5 mg/kg), sufentanil (0.5 ug/kg), and rocuronium (0.6 mg/kg)
anesthesia maintenance: infusion of propofol (4-12 mg/kg/h), adjusted intraoperatively based on PSI values to maintain PSI between 25 and 50. Other maintenance medications were identical to those in t

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ASA classification I-III; 2. Laparoscopic colorectal cancer surgery scheduled under general anesthesia is planned; 3. Body mass index (BMI) : 18-30 kg/m^2; 4. Age: 18-80 years old; 5. Normal mental state, with certain comprehension and communication skills; 6. Informed consent experimental protocol

Exclusion criteria

Exclusion criteria: 1. There are visual, language or hearing impairments, and they are unable to cooperate with the assessment of postoperative fatigue; 2. Suffering from neuropsychiatric diseases (such as severe dementia) And the severity has affected the postoperative assessment; 3. Severe fatigue existed before the operation (Visual Analogue Scale score > 5 points); 4. Long-term abuse of alcohol, opioids, and benzodiazepines; 5. Severe cardiovascular diseases and liver and kidney dysfunction; 6. received radiotherapy and chemotherapy within 6 months before the operation

Design outcomes

Primary

MeasureTime frame
Incidence of fatigue syndrome on postoperative day 3 (ICFS-10 score =24);

Secondary

MeasureTime frame
Christensen Fatigue Score;ICFS-10 Fatigue Score;Postoperative Quality of Recovery (QoR-15) Assessment (Physical Comfort, Emotional State, Self-Care, Psychological Support, Pain);Mean Arterial Pressure (MAP);Heart Rate;Patient State Index (PSI) Value;Pain Score (NRS/VAS);Ramsay Sedation Scale;Serum C-Reactive Protein (CRP) Concentration;Systemic Inflammatory Response Index (SIRI);Procalcitonin Concentration;Time to First Ambulation Postoperatively;Time to First Flatus Postoperatively;Rescue Analgesia Requirement Postoperatively;Postoperative Sleep AIS Score;Incidence of Postoperative Delirium;

Countries

China

Contacts

Public ContactJiao Hao

The Affiliated Hospital of Xuzhou Medical University

jiaohaoyishi@163.com+86 18168777312

Outcome results

None listed

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