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Remimazolam versus propofol for the postoperative quality of recovery in elderly patients undergoing painless colonoscopy: a randomized, controlled non-inferiority trial

Remimazolam versus propofol for the postoperative quality of recovery in elderly patients undergoing painless colonoscopy: a randomized, controlled non-inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095232
Enrollment
Unknown
Registered
2025-01-03
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Colorectal disease

Interventions

A Group (Remimazolam):Induction: Sufentanil 0.1 µg/kg + Remimazolam 0.15-0.25 mg/kg. Maintenance: Remimazolam 0.5-1.5mg/kg/h. Reversal: Flumazenil (0.5mg) ,naloxone (0.3ug/kg)
B Group (Propofol):Induction: Sufentanil 0.1 µg/kg + Propofol 1.5-2.5 mg/kg. Maintenance: Propofol 4-8mg/kg/h. Reversal: Naloxone (0.3ug/kg)

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age older than 65 years; 2.Body Mass Index (BMI) from 18.5 to 30 kg/m²; 3.Patients receiving elective colonoscopy treatment (Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Colorectal polypectomy), with a surgical duration more than 30 minutes. 4.American Society of Anesthesiologists (ASA) classification I to III; 5.Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subjects refuse to participate in this study; 2.History of severe cardiovascular, neurological, respiratory, liver, kidney, and metabolic disorders; 3.History of abnormal recovery from anesthesia; 4.Heart rate 180mmHg and/or DBP > 110mmHg) or hypotension (BP < 90/60 mmHg) 7.Patients with neuromuscular disorders or mental disorders; 8.History of analgesics or tranquilizers abuse; 9.Other occasions when the investigators determined inappropriate.

Design outcomes

Primary

MeasureTime frame
The postoperative quality of recovery-15 scale (QoR-15);

Secondary

MeasureTime frame
Vital signs at different times ( blood pressure, heart rate, oxygen saturation [ SpO2 ], prtial pressure of end tidal carbon dioxide [PetCO2], respiration rate, [RR]);Time required from anesthesia to laryngeal mask airway(LMA) insertion ;Time required from LMA insertion to the start of operation;Duration of the operation;Recovery time;Duration from the removal of the LMA to leaving operating room.;Time in postanesthesia care unit(PACU);Modified Observer's Alertness/Sedation(MOAA/S) scale;Body motion grade;Frequency of intestinal motility;Total use of propofol;Total use of remimazolam;The rate of hypotension;The incidence of low oxygen saturation;The incidence of bradycardia, or tachycardia;The frequency and dosage of vasopressor administration during the operation;The frequency and dosage of atropine administration during the operation;Satisfaction evaluation (visual analogue scale,VAS);The rate of adverse reactions (nausea, vomiting, dizziness, abdominal distension, drowsiness, throat pain, and jaw discomfort);The incidence of postoperative delirium;Total duration of mechanical ventilation;The postoperative quality of recovery-15 scale (QoR-15);

Countries

China

Contacts

Public ContactGuo Ruijuan

Beijing Friendship Hospital, Capital Medical University

guoguo12015@163.com+86 138 1181 0632

Outcome results

None listed

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