The increase in the number of clinical trials, driven mainly for career advancement mandated by regulatory bodies such as Medical Council of India risks output of substandard publications and also wastage of resources. There are also concerns of inadequate reporting and wilful concealment of results. The quality and quantity of the output become questionable evidences for medical practice. Lack of transparency can lead to disillusionment of the public in the medical field. Clinical trials registration seeks to regulate and streamline the clinical trials by mandating registration in various registries, through free for registration sites such as Clinical Trials Registry of India (CTRI). The guidelines are based on the World Health Organisation's International Clinical Trials Registry Platform (ICTRP). This review aims to highlight the types of registries, the registration process, the data that need to be registered, the guide to use the CTRI and the search options in CTRI and ICTRP. The role of International Committee of Medical Journal Editors is also highlighted in regard to not only registration but also on the publication of trial registration number in the manuscript.

Background and Aims: Patient satisfaction from a pre-anaesthetic clinic (PAC) visit is greatly influenced by time spent there. We aimed to determine time spent in a PAC without an appointment system and the factors affecting the same. Methods: Four hundred and eight patients coming to PAC were tracked using a time-motion study model. Time spent in waiting and consultation was recorded. Independent variables potentially affecting time spent were documented. Patients were grouped based on independent variables, and the groups were compared for significant differences using appropriate statistical tests. Workload pending on physicians was calculated on an hourly basis by counting number of patients waiting and number of physicians in PAC. Results: Non-parametric statistical tests were used for analysis because the data were not normally distributed. The median and inter-quartile range for waiting time, consultation time and total time were 60 (30–90) minutes, 17 (12–26) minutes and 79 (53–111) minutes, respectively. There was considerable variation in all three. Waiting time was significantly lower in patients posted for same-day surgery or those arriving on a stretcher or wheelchair. Consultation time was correlated with American Society of Anesthesiologists physical status and grade of surgery. Most patients arrived in the morning rather than at equal intervals. Waiting time and workload were therefore maximum in the midmorning and dropped rapidly in the afternoon. Conclusion: Large variability in waiting time is linked to lack of an appointment system, and to patients being seen out of turn.

Background and Aims: One of the reasons for continued routine pre-operative testing practice is the identification of hidden problems which may affect perioperative management. This study was aimed to assess the prevalence of abnormal test results, their impact on perioperative management and cost-effectiveness for detecting such abnormalities. Methods: This observational study was conducted by screening the files of the patients attending pre-anaesthetic check-up during December 2016–January 2017. Patients' physical status, surgery grade, normal and abnormal test results and different impacts were noted and expressed in absolute numbers/percentage. Number needed to investigate (NNI) to detect a significant abnormality was calculated. Results: Data of 414 patients (46.3% male) with mean ± standard deviation age 43.78 ± 17.24 years and 58.65 ± 12.93 kg weight were analysed. Patients were mostly American Society of Anesthesiologists II and underwent National Institute of Clinical and Health Excellence Grade 3 surgeries. Totally, 345 (11.6%) test results were abnormal. Only 56 (16.2%) abnormalities had an impact in terms of referral, further investigations or delay. Twenty were significant in terms of changing perioperative anaesthetic management. Laboratory abnormalities with non-significant impact resulted in median delay of 3 days (range 1 to 12 days). The NNI for a significant impact and detecting new abnormality was 21 and 28, respectively. Conclusion: Majority (57.2%) of the patients had at least one abnormal routine test result but only 1.8% abnormalities had significant impact. The NNI to find a significant impact or hidden comorbidity was more than 20.

Background and Aims: Early identification of malnutrition among hospitalised patients is essential to institute appropriate patient-specific nutritional strategies. This study was conducted to evaluate the nutritional status of medical patients at admission to the adult intensive care unit (ICU) and to identify factors which prevent attainment of daily feeding goals in them. Methods: This was a 1 year prospective, observational study on 200 medical adult ICU patients. The study was carried out based on daily documentation. The primary outcome was the nutritional status of medical Patients at admission to the adult ICU. The tests for statistical analysis used were independent t test, Chi-square test, Fisher's exact test and multivariate logistic regression analysis. Results: Out of the 200 patients in our study, 45%, 48.5% and 9% of patients had mild, moderate and severe malnutrition, respectively, corresponding to subjective global assessment (SGA) rating A,B and C, respectively. The most common reasons for non-attainment of daily feeding goals were delayed feed procurement (17.57%), and feeds being held for procedures (16.36%). The overall mean length of ICU stay was 8.63 ± 7.26 days, and the ICU mortality rate was 47.5% (95/200). Patients with SGA rating B and C at admission had higher risk of mortality in the ICU, with an adjusted odds ratio of 3.54 (95% confidence interval [CI]- 1.71–7.33, P = 0.001) and 11.11 (95% CI-2.26–54.66, P = 0.003), respectively. Conclusion: Malnutrition is commonly present at admission among medical ICU patients, and is associated with higher ICU mortality.

Background and Aims: Early identification of malnutrition among hospitalised patients is essential to institute appropriate patient-specific nutritional strategies. This study was conducted to evaluate the nutritional status of medical patients at admission to the adult intensive care unit (ICU) and to identify factors which prevent attainment of daily feeding goals in them. Methods: This was a 1 year prospective, observational study on 200 medical adult ICU patients. The study was carried out based on daily documentation. The primary outcome was the nutritional status of medical Patients at admission to the adult ICU. The tests for statistical analysis used were independent t test, Chi-square test, Fisher's exact test and multivariate logistic regression analysis. Results: Out of the 200 patients in our study, 45%, 48.5% and 9% of patients had mild, moderate and severe malnutrition, respectively, corresponding to subjective global assessment (SGA) rating A,B and C, respectively. The most common reasons for non-attainment of daily feeding goals were delayed feed procurement (17.57%), and feeds being held for procedures (16.36%). The overall mean length of ICU stay was 8.63 ± 7.26 days, and the ICU mortality rate was 47.5% (95/200). Patients with SGA rating B and C at admission had higher risk of mortality in the ICU, with an adjusted odds ratio of 3.54 (95% confidence interval [CI]- 1.71–7.33, P = 0.001) and 11.11 (95% CI-2.26–54.66, P = 0.003), respectively. Conclusion: Malnutrition is commonly present at admission among medical ICU patients, and is associated with higher ICU mortality.

Background and Aims: Although spinal anaesthesia (SA) is nowadays the preferred anaesthesia technique for caesarean section (CS), it is associated with considerable haemodynamic effects, such as maternal hypotension. This study aimed to evaluate a wide range of variables (related to parturient and anaesthesia techniques) associated with the incidence of different degrees of SA-induced hypotension during elective CS. Methods: This prospective study was conducted on 511 mother–infant pairs, in which the mother underwent elective CS under SA. The data were collected through preset proforma containing three parts related to the parturient, anaesthetic techniques and a table for recording maternal blood pressure. It was hypothesized that some maternal (such as age) and anaesthesia-related risk factors (such as block height) were associated with occurance of SA-induced hypotension during elective CS. Results: The incidence of mild, moderate and severe hypotension was 20%, 35% and 40%, respectively. Eventually, ten risk factors were found to be associated with hypotension, including age >35 years, body mass index ≥25 kg/m², 11–20 kg weight gain, gravidity ≥4, history of hypotension, baseline systolic blood pressure (SBP) <120 mmHg and baseline heart rate >100 beats/min in maternal modelling, fluid preloading ≥1000 ml, adding sufentanil to bupivacaine and sensory block height >T₄in anaesthesia-related modelling (P < 0.05). Conclusion: Age, body mass index, weight gain, gravidity, history of hypotension, baseline SBP and heart rate, fluid preloading, adding sufentanil to bupivacaine and sensory block hieght were the main risk factors identified in the study for SA-induced hypotension during CS.

Background and Aims: Effect of serum 25-hydroxy vitamin D (25[OH] D) levels on the recovery of critically ill mechanically ventilated patients is unclear. Hence, this study assessed 25(OH)D levels of critically ill patients on mechanical ventilation at the time of admission to the Intensive Care Unit (ICU) and its relationship with clinical outcome. Methods: In this prospective observational pilot study, forty adult patients receiving mechanical ventilation in the ICU were included. Serum 25(OH)D was assessed within 24 h of admission. Primary outcome was 30-day mortality and secondary outcomes were days on mechanical ventilation, ICU-length of stay (ICU-LOS), days to reach spontaneous breathing trial (SBT), requirement of advanced care modality and complications. Results: Seventy-five percent patients had low serum 25(OH)D (65% deficient and 10% insufficient). Between patients with low and normal vitamin D , there was no significant difference in 30-day mortality (10% vs. 16.7%; P = 0.81), days on mechanical ventilation (16.2 ± 8.9 vs. 19.9 ± 8.4; P = 0.23), ICU-length of stay (18.7 ± 8.5 vs. 23.3 ± 11.4; P = 0.28), days to reach SBT (11.5 (0–20) vs. 21 (8–30); P = 0.78), complications developed during ICU stay (P = 0.60) and need for advanced care modalities (P = 0.72). Conclusion: Low Vitamin D level at admission did not affect 30-day mortality of critically ill patients on mechanical ventilation.

Background and Aims: Routine use of pre-procedural ultrasound guided midline approach has not shown to improve success rate in administering subarachnoid block. The study hypothesis was that the routine use of pre-procedural (not real time) ultrasound-guided paramedian spinals at L5-S1 interspace could reduce the number of passes (i.e., withdrawal and redirection of spinal needle without exiting the skin) required to enter the subarachnoid space when compared to the conventional landmark-guided midline approach. Methods: After local ethics approval, 120 consenting patients scheduled for elective total joint replacements (Hip and Knee) were randomised into either Group C where conventional midline approach with palpated landmarks was used or Group P where pre-procedural ultrasound was used to perform subarachnoid block by paramedian approach at L5-S1 interspace (real time ultrasound guidance was not used). Results: There was no difference in primary outcome (difference in number of passes) between the two groups. Similarly there was no difference in the number of attempts (i.e., the number of times the spinal needle was withdrawn from the skin and reinserted). The first pass success rates (1 attempt and 1 pass) was significantly greater in Group C compared to Group P [43% vs. 22%, P = 0.02]. Conclusion: Routine use of paramedian spinal anaesthesia at L5-S1 interspace, guided by pre-procedure ultrasound, in patients undergoing lower limb joint arthroplasties did not reduce the number of passes or attempts needed to achieve successful dural puncture.

Background and Aims: Mostly, institutions in India have single post-anaesthesia care unit (PACU) which follows traditional time-based discharge (TBD) method. Recently, it has been classified into PACU Phase I and Phase II, and criteria-based discharge (CBD) method has been used. This study primarily compares CBD versus TBD methods in moving patients through PACU, and other non-clinical factors causing delay in shifting. Methods: One hundred patients, aged 18–65 years, American Society of Anesthesiologist's physical status I and II, scheduled for elective minor surgeries under general anaesthesia were studied. White's fast-track score in operating room (OR) and modified Aldrete's score (CBD time) in PACU were recorded. Patients were scheduled to discharge at 60 min based on TBD method. The mean CBD time and actual discharge time from PACU were statistically compared with TBD time. Other non-clinical factors delaying the discharge were also studied. Results: Eighty-five percent of patients achieved acceptable White's fast-track score in OR. The TBD time (60 min) was compared with the mean CBD time (10.70 ± 2.56 min) and actual discharge time (79.75 ± 12.98 min), which were found to be statistically significant. Primarily, anaesthesiologists' busy schedule was accountable for delay in discharge. Conclusion: The study concluded that in patients undergoing ambulatory minor surgeries, discharge times based on Criterion Based Discharge scoring systems such as modified Aldrete's and White's-fast are significantly lower in PACU Phase I as compared to the traditional Time Based Discharge method.

Background and Aims: Post-operative sore throat (POST) is often considered an inevitable consequence of tracheal intubation. This study was performed to compare the effect of inhaled budesonide suspension, administered using a metered dose inhaler, on the incidence and severity of POST. Methods: In this prospective randomised study, 46 patients undergoing laparoscopic surgeries lasting <2 h were randomly allotted into two equal groups. Group A received 200 μg budesonide inhalation suspension, using a metered dose inhaler, 10 min before intubation, and repeated 6 h after extubation. No such intervention was performed in Group B. The primary outcome was the incidence and severity of POST. Secondary outocomes included the incidence of post-operative hoarseness and cough. Pearson's Chi-square test, Fisher's exact test and Independent sample t-test were used as applicable. Results: Compared to Group B, significantly fewer patients had POST in Group A at 2, 6, 12 and 24 h (P < 0.001). Although more patients in Group B had post-operative hoarseness of voice and cough at all-time points, the difference was statistically significant only at 12 h and 24 h for post-operative hoarseness and at 2 h and 12 h for post-operative cough. Severity as well as the incidence of POST showed downward trends in both groups over time, and by 24 h no patient in Group A had sore throat. Conclusion: Inhaled budesonide suspension is effective in significantly reducing the incidence and severity of POST.

Methaemoglobinaemia is a rare but potentially dangerous haemoglobinopathy that is often underdiagnosed. It is one of the causes for unexplained cyanosis with dark-coloured blood, especially in the absence of cardiac or pulmonary pathology. Not uncommonly so, it is an incidental perioperative finding in cases of dark-coloured blood not improving with oxygen in apparently acyanotic patients. The present case report is of a child with deaf-mutism posted for cochlear implant surgery who presented with 'chocolate-coloured blood' in the surgical field, despite blood gas analysis showing a normal partial pressure of oxygen.

Post-operative pain after minimally invasive video-assisted thoracoscopic surgery (VATS) in adults is commonly managed with oral and parenteral opioids and invasive regional techniques such as thoracic epidural blockade. Emerging research has shown that the novel erector spinae plane (ESP) block, can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic and chronic neuropathic thoracic pain in adults. We illustrate this by presenting a paediatric case of VATS, in which an ESP block provided better analgesia, due to greater dermatomal coverage, as well as reduced side-effects when compared with a thoracic epidural that had previously been employed on the same patient for a similar procedure on the opposite side.