Skip to content

The Effect of Low-Dose Muscle Relaxants on the Incidence of Hypotension During Anesthesia Induction with Laryngeal Mask Airway in Elderly Surgical Patients: A Single-Center, Randomized, Controlled Clinical Trial

The Effect of Low-Dose Muscle Relaxants on the Incidence of Hypotension During Anesthesia Induction with Laryngeal Mask Airway in Elderly Surgical Patients: A Single-Center, Randomized, Controlled Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105768
Enrollment
Unknown
Registered
2025-07-10
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Post-induction hypotension

Interventions

Experimental:Administer 0.2 mg/kg rocuronium and 0.2 µg/kg sufentanil, followed by a propofol bolus at a rate of 2 mg/s until the mandibular joint ligaments relax and the Bispectral Index (BIS) is bel
Control group:Administer 0.2 µg/kg sufentanil, followed by a bolus of 1.5 mg/kg propofol at an injection rate of 2 mg/s. Monitor the Bispectral Index (BIS), and no muscle relaxant is used.

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged >= 65 years 2) Scheduled to undergo elective non-cardiac surgery under general anesthesia 3) American Society of Anesthesiologists (ASA) physical status classification of 1~3 4) Signed informed consent form

Exclusion criteria

Exclusion criteria: 1) Contraindications for radial artery catheterization (infection or trauma at/near the puncture site; coagulation disorders; vascular diseases such as vasculitis, arterial stenosis, or aneurysm; positive Allen’s test; catheterization site adjacent to the surgical field) 2) High risk of aspiration 3) Severe limited mouth opening or abnormal oropharyngeal anatomy 4) Severe pharyngeal inflammation, edema, hematoma, abscess, or tumor 5) Allergy to propofol, sufentanil, or rocuronium 6) Body mass index (BMI) >30kg/m 7) Systolic blood pressure difference between left and right arms exceeding 20mmHg 8) Severe cardiovascular diseases (congestive heart failure, unstable angina, myocardial infarction, NYHA class 3~4) 9) Severe hepatic or renal dysfunction 10) Myasthenia gravis patients 11) History of psychiatric disorders, use of psychotropic medications, or cognitive impairment 12) Emergency surgery 13) Position change within 15 minutes after anesthesia induction

Design outcomes

Primary

MeasureTime frame
Hypotension within the first 15 minutes after induction of anesthesia;

Secondary

MeasureTime frame
Propofol Induction Dose;Area Under MAP 60, 50, and 40 mmHg(AUC-MAP);Duration of MAP Below 65, 60, 50, and 40 mmHg;The proportion (%) of subjects with MAP values below 65, 60, 50, and 40 mmHg;The proportion (%) of subjects with MAP remaining below 65, 60, 50, and 40 mmHg for at least 1 consecutive minute;The area under the curve (AUC) for MAP values above 100, 110, 120, and 140 mmHg;The time from discontinuation of anesthetic maintenance drug infusion to laryngeal mask airway (LMA) removal;The incidence of postoperative sore throat at 1 days after surgery;First-attempt success rate of laryngeal mask airway (LMA) insertion;Peak and mean airway pressures within 15 minutes after induction of anesthesia;Incidence of intraoperative complications: patient movement, coughing, laryngospasm, pulmonary aspiration, and LMA dislodgment;doses of phenylephrine(mg), ephedrine(mg), and atropine(mg);Total crystalloid infusion volume (mL);Incidence of postoperative delirium within 3 days after surgery;Incidence of acute kidney injury (AKI) within 3 days after surgery;Incidence of postoperative pulmonary complications (PPCs) within 3 days after surgery;Postoperative hospital length of stay;30-day and 90-day postoperative readmission rates;

Countries

China

Contacts

Public ContactWangyuan Zou

Xiangya Hospital of Central South University

wangyuanzou@csu.edu.cn+86 180 7313 7075

Outcome results

None listed

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