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Sugammadex Sodium versus Neostigmine for Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: A Randomized Controlled Trial

Sugammadex Sodium versus Neostigmine for Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124125
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-27
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Postoperative delirium

Interventions

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Meet the surgical indications and plan to undergo hip replacement surgery; 2. Age: 60-90 years old; 3. ASA level 1-3; 4. Clearly understand, voluntarily participate in the study, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients known to be allergic to sulfosuccinimide sodium and to the components of neostigmine. 2. Presence of mental health drugs or alcohol abuse. 3. Patients who are unable to tolerate the various adverse reactions associated with sugenglucose, neostigmine, and atropine. 4. Patients with severe cardiovascular and cerebrovascular diseases, respiratory diseases, severe immune system disorders, and severe abnormalities in liver and kidney function. 5. A preoperative brief mental status examination scale (MMSE) score of <=20 points. 6. Severe mental disorders, cognitive dysfunction, co-occurrence of any psychiatric condition, cranial or scalp injuries. 7. Visual or hearing impairments, difficulties with communication. 8. It is anticipated that post-operative admission to the intensive care unit (ICU) will be required (defined as severe cardiovascular or pulmonary disease with an ASA physical status classification of IV and requiring post-operative intensive care). 9. Situations that make it inadvisable for an individual to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 3 days after surgery;

Secondary

MeasureTime frame
Number and subtypes of delirium episodes;MMSE score on postoperative day 1 and day 3;Incidence of MMSE decreased by >= 1 standard deviation from baseline;Pain scores at 2, 24, 48 and 72 hours postoperatively;HADS-A scores on postoperative days 1 and 3;HADS-D scores on postoperative days 1 and 3;Heart rate at 1 minute (T3), 3 minutes (T4), and 5 minutes (T5) after administration of neuromuscular block antagonists;Blood pressure at 1 minute (T3), 3 minutes (T4), and 5 minutes (T5) after administration of neuromuscular block antagonists;Time from the end of anesthesia to extubation;The train-of-four ratio (TOFR) was restored to 90% of the time;TOFR during extubation;Incidence of delayed extubation;The incidence of postoperative SpO2 < 95% and SpO2 < 90%;PACU length of stay;Postoperative serological inflammatory and biochemical indicators;First venting time;Time to first bowel movement;Time of first out-of-bed activity;Number of days in hospital;Incidence of salvage analgesia;Incidence of hypertension and hypotension in the PACU;

Countries

China

Contacts

Public ContactYang Chun

The First Affiliated Hospital of Nanjing Medical University

chunyang@njmu.edu.cn+86 182 6006 2666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026