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Sugammadex to prevent complications after general anesthesia in the elderly

Sugammadex to prevent residual neuromuscular block and other complications after general anesthesia in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17481425
Enrollment
351
Registered
2020-01-27
Start date
2015-01-02
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

Post-operative residual curarisation and its impact on respiratory function after anesthesia and possible postoperative pulmonary complications Surgery

Interventions

Overall, 351 patients aged 65-91 years were examined. Patients were anaesthetised at the M. Kopernik Provincial Multispeciality Centre of Oncology and Traumatology in Lodz. Spirometry and MMSE (Mini-M

Sponsors

Medical University of Lodz
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Physical status ASA class I-III 2. Patients verbally responsive and maintaining logical communication, understanding and responding to commands 3. Patients without pain disabling cooperation. Patients who were not under the clear influence of narcotic analgesics, psychotropic drugs, or in deep sedation 4. Patients scheduled for elective surgery 5. Patients scheduled for general surgery, endocrinology surgery, vascular surgery, trauma surgery, urological or oncological surgery 6. Neurosurgery and thoracic surgery patients were excluded from the study due to the expected difficulty in interpreting the results

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria or lack of consent

Design outcomes

Primary

MeasureTime frame
Post-operative residual curarisation, assessed using neuromuscular accelerometry after sugammadex or neostygmine injection after GA in elderly. After the immobilization of the hand, the ulnar nerve was stimulated to provoke the contraction of the adductor muscle of the thumb, and the response was recorded and measured using a piezoelectric acceleration transducer. The TOF mode is the most appropriate for the monitoring of the reversal of effects induced by nondepolarizing muscle relaxants. Each patient whose TOF was lower than 0.9 is considered to have risk of post operation residual curarisation.

Secondary

MeasureTime frame
1. Respiratory efficacy after GA in elderly, assessed by spirometry at one day before surgery and one hour after discharge from the PACU. The principles of the procedure will be explained to the patient, and then the test will be done using a portable handheld spirometer (Spirobank, MIR) with digital disposable turbines. The patient will be seated, and a clip is placed on his/her nose to close the nostrils. The patient breath calmly and hold the mouthpiece with the teeth. When instructed, the patient take a deep breath in, and then exhale as hard as he/she can. The test was repeated three times and the highest value was recorded. FEV1 and FVC is measured and evaluated 2. Mental status assessed using MMSE test (Mini-Mental State Examination) by an anaesthetist one day before surgery and in the morning within 24 h after surgery. The test consists of 30 questions, and examines orientation to time and place, registration, attention, calculation, recall, language, and ability to follow simple commands, including writing and drawing. Each answer is scored. The maximum total score is 30 points. Scores in the range of 27-30 points indicate normal cognition. Scores 24-26 points may indicate cognitive impairment. Scores of 19-23 points indicate mild impairment, and scores 11-18 points moderate cognitive impairment. Scores 10 or fewer points indicate severe impairment

Countries

Poland

Outcome results

None listed

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