RESUMO
A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052.
RESUMO
Background and Aims: Major complications of central neuraxial block (CNB) are rare and their incidence in India is not known. This information is essential for explaining risk and medico-legal concerns. The present multi-centre study in Maharashtra was conducted to provide insight into the characteristics of rare complications following this popular anaesthetic technique. Methods: Data were collected from 141 institutes to study the clinical profile of CNB. Incidence of complications like vertebral canal haematoma, abscess, meningitis, nerve injury, spinal cord ischaemia, fatal cardiovascular collapse, and drug errors was collected over one year. Complications were reviewed by audit committee to assess causation, severity, and outcome. 'Permanent' injury was defined as death or neurological symptoms persisting for more than six months. Results: Spinal anaesthesia (SA) was the most frequently used CNB in 88.76% patients. Bupivacaine and an adjuvant were used in 92.90% and 26.06% patients, respectively. Eight major complications (four neurological and four cardiac arrests) were reported in patients receiving SA. In seven of eight instances, SA was responsible or contributory for complication. The pessimistic incidence of complications (included cases where CNB was responsible; contribution was likely, unlikely and could not be commented) was 8.69/lakh and optimistic incidence (included cases where CNB was responsible or contribution was likely) was 7.61/lakh. 'Pessimistically' and 'optimistically' there were three deaths including one death due to quadriplegia following epidural haematoma after SA. Five out of eight patients recovered completely (62.5%). As only eight patients had complications of different types, it was difficult to establish statistical correlation of major complications with demographic or clinical parameters. Conclusion: This study was reassuring and suggested that the incidence of major complications following CNB was low in Maharashtra.
RESUMO
BACKGROUND AND AIMS: Incidence of major neurological complications following central neuraxial blockade (CNB) in India is not known. This information is essential for explaining risk preoperatively to patients and for medico-legal purposes. This study was undertaken to assess feasibility (recruitment process, protocol adherence, resources mobilisation, data management and evaluation of scientific outcome) for planning multicentric studies on major neurological complications following CNB at state/national level. METHODS: This was a hospital-based, multicentre pilot study, with cross-sectional and follow-up components. Patients receiving CNB either perioperatively or during acute/chronic pain management were included in the study. Thirty-six randomly selected tertiary and nontertiary care institutes were included. Details of demographic information, CNB procedure and major neurological complications were collected anonymously via online tools. Feedback about study feasibility was collected from participating anaesthesiologists and study team. RESULTS: Selected institutes continued participation throughout study period. About 99.98% of eligible patients were enroled. Complete data collection of 8053 patients and analysis was possible. Regular reminders from study coordinators helped to optimise data collection. Tertiary care institutes contributed to 74.50% of data. About 64.96% patients were females. Spinal anaesthesia was the most frequently used neuraxial block (93.41%). Bupivacaine and adjuvant were used in 95.53% and 16.5% patients, respectively. Two patients developed cardiac arrest and cause-effect relationship with CNB was established. Participants' recruitment, protocol adherence, resources mobilisation, data management and evaluation of scientific outcomes were feasible. CONCLUSION: A multicentre state/nationwide study can be conducted based on this first-of-its-kind pilot study in India.