Spinal versus general anaesthesia and serious complications in older patients undergoing hip fracture surgery in Germany: a multicentre randomised clinical trial

BACKGROUND: Evidence on the optimal anaesthetic technique for hip fracture surgery is scarce. We evaluated the effects of spinal versus general anaesthesia on all-cause mortality and new-onset serious cardiac and pulmonary complications in older patients undergoing hip fracture surgery. METHODS: We conducted the pragmatic, randomised, two-arm parallel-group, open-label, multicentre Improve Hip Fracture Outcome in the Elderly Patient (iHOPE) trial across 22 German hospitals. Patients aged 65 years or older undergoing hip fracture surgery were randomly assigned (1:1) using a web-based system, stratified by centre, to general anaesthesia (n=389) or spinal anaesthesia (n=386). The primary outcome was time to first occurrence of a composite outcome comprising all-cause mortality and new-onset serious cardiac and pulmonary complications within 30 days post-surgery. The primary analysis followed the intention-to-treat principle and was based on the full analysis set. iHOPE was stopped early, after enrolment of 75% of the target sample size (n=1032), on the recommendation of the data and safety monitoring board, owing to slow recruitment and reduced staffing during the COVID-19 pandemic. iHOPE was registered with the German Clinical Trials Register (DRKS00013644). FINDINGS: Between April, 2018, and February, 2023, iHOPE enrolled 775 patients. Four patients were excluded before analysis because of erroneous randomisation, withdrawal of consent, death before anaesthesia, or postrandomisation ineligibility, leaving a full analysis set of 771 patients, of whom 528 (69%) were female. The primary endpoint occurred in 55 (14%) of 385 patients in the spinal anaesthesia group and 47 (12%) of 386 patients in the general anaesthesia group. Kaplan-Meier curves showed similar event-free survival in the two groups. The mean (SD) time to first occurrence of the composite outcome was 10·2 (9·7) days in the spinal anaesthesia group and 10·5 (10·4) days in the general anaesthesia group. The primary composite outcome did not differ between the two anaesthetic techniques (centre-stratified hazard ratio: 1·23, 95% CI 0·83-1·82; p=0·29). Adverse events occurred in 320 (83%) of 385 patients in the spinal anaesthesia group and 344 (89%) of 386 patients in the general anaesthesia group, whereas serious adverse events occurred in 109 (34%) of 319 patients in the spinal anaesthesia group and 105 (31%) of 344 patients in the general anaesthesia group. No treatment-related deaths occurred. INTERPRETATION: Our findings should be interpreted with caution given the premature trial termination, modest statistical power, and high treatment crossover. However, findings add to the evidence supporting an individualised anaesthetic approach, and suggest that there is no clinically meaningful difference between spinal anaesthesia and general anaesthesia for hip fracture surgery. FUNDING: German Federal Ministry of Education and Research.