Clinical Trials Logo

Filter by:
NCT ID: NCT03535025 Completed - Elective Surgeries Clinical Trials

Postoperative Quality of Recovery in Patients Receiving Anaesthesia

Start date: January 2, 2018
Phase:
Study type: Observational

The investigator's study is designed to evaluate the recovery of patients receiving anaesthesia for surgeries; in different domains like the physiological, nociceptive, cognitive and emotional to the participants' preoperative state.

NCT ID: NCT03479320 Completed - Pain, Postoperative Clinical Trials

Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation

Start date: March 28, 2018
Phase: Phase 4
Study type: Interventional

This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request

NCT ID: NCT03476694 Recruiting - Clinical trials for Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture

Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.

Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study has compared the different volumes of drug on success rate and diaphragmatic motility.So in this study , the investigators want to compare the incidence of hemidiaphragm paralysis and success of block with different volumes of local anaesthetic , so that the lowest effective dose with higher safety profile can be determined.

NCT ID: NCT03451695 Completed - Clinical trials for Chronic Pain Post-Procedural

Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

The incidence of chronic post-surgical pain (CPSP) after caesarean section (CS) is reported to be as high as 18%, reflecting it to be a significant clinical problem. Studies related to prevention of progression of acute post-CS pain to its chronicity are sparse. Current guidelines on post-CS analgesia recommend the use of intrathecal (IT) opioids to spinal anaesthesia for improved post-CS pain relief. Despite its frequent use, studies related to the IT morphine use and its association with post-CS chronic pain are lacking. A recent prospective observation study revealed a significant reduction in persistent pain after CS when IT morphine was used as an adjuvant to spinal anaesthesia. However, there is no any randomized controlled trial (RCT) that has explored this association to date. We hypothesized that spinal morphine would reduce the incidence of persistent pain after CS.

NCT ID: NCT03450499 Completed - Clinical trials for Non Elective Cesarean Section and Ketamine Analgesia

Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.

NCT ID: NCT03447340 Completed - Hypertension Clinical Trials

Nepal Pioneer Worksite Intervention Study

NPWIS
Start date: November 9, 2016
Phase: N/A
Study type: Interventional

The proposed project will develop, implement, and test methodology for the design of an acceptable, effective intervention for diabetes prevention in a real-world setting. By determining the effectiveness of the intervention, the study will serve to guide the translation of research into routine public health prevention programs and policy. And, the hands-on experience will directly support the development of expertise, tools and training to advance translational science as a discipline. The study aims to test the effectiveness of an environmental and individual level intervention to prevent diabetes at Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure: Effectiveness of a canteen intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; a systolic blood pressure decrease (SBP) ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a behavioral intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; SBP decrease ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake after six months of the canteen only (CO) intervention compared to the change over six months during the control period. Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after six months of behavioral intervention plus the canteen (CB) intervention compared to the change over six months during CO. We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant characteristics of the participants (age, sex, education, income, marital status, and family history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food consumption data from the administrative database in DH-KUH. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol, triglycerides). We will measure height, weight, waist circumference, hip circumference, and blood pressure. After 6 months of control period, the participants will receive the canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions. After six months of the canteen intervention, half of the participants will be randomized to receive the behavioral intervention. The behavior intervention will be a combination of intensive education sessions, group counselling, goal setting and monitoring based on the Diabetes Prevention Program (DPP). The primary analysis will use χ^2test use to compare (a) Proportion of individual with score ≥ 2 during CO intervention to the proportion of individual with score ≥ 2 during the control period; (b) Proportion of individual with score ≥ 2 during CB intervention to the proportion of individual with score ≥ 2 during CO intervention. We will conduct a logistic regression with the proportion of individual with score ≥ 2 as outcome and CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the change in healthy food intake and HbA1c during CO to the change in healthy food intake and HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to the change in healthy food intake and HbA1C% during CO period. We will conduct linear regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further analysis will adjust for confounding in time-varying variables and assess effect modification.

NCT ID: NCT03427502 Completed - Nasal Polyps Clinical Trials

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS). Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block. Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.

NCT ID: NCT03387228 Completed - Clinical trials for Low Back Pain, Mechanical

Pain Education for Patients With Low Back Pain in Nepal: A Feasibility Study

PEN-LBP
Start date: February 16, 2018
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate the feasibility of a full randomized clinical trial for assessing the effects of pain education as an intervention for patients with LBP in a physiotherapy facility in Nepal. The primary objectives of the study are related to feasibility of randomized clinical trial including: (1) willingness to participate in a clinical trial, (2) acceptability of random allocation to one of the two study groups, (3) feasibility of blinding the assessor(s), (4) eligibility and recruitment rates, (5) acceptability of screening procedures, (6) possible contamination between the groups, (7) credibility of pain education for patients with LBP, (8) adherence to intervention, (9) satisfaction of treatment, and (10) difficulty in understanding the content of pain education. To address the study objectives, an assessor-blinded, two arm randomized feasibility study was designed. Forty patients with LBP will be randomly allocated to one of the two study arms, (1) pain education in the experimental group, and (2) evidence based care in the control group (CG).

NCT ID: NCT03382548 Completed - Clinical trials for Ventilator Associated Pneumonia

Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection

REGARD_VAP
Start date: February 21, 2018
Phase: Phase 3
Study type: Interventional

Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical trials studying antibiotic duration for VAP caused by predominantly non-fermenting Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the potential to improve individual patient outcomes and indirectly benefit other patients by reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU. The study aims to demonstrate clinical non-inferiority-superiority of a short duration of antibiotics (up to 7 days) versus prolonged antibiotic therapy (as per physician preference) in adults with VAP in Asia. Patients who have been ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP according to the US Centers for Disease Control and Prevention VAP criteria. Recruited patients will be reviewed daily for clinical signs of stability including temperature <38°C for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be randomised once they fulfill these clinical criteria of stability. In the intervention arm, antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the control arm, antibiotics should be at least 7 days with the exact duration decided by the managing physicians. The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP (7 days or less depending on clinical response) is not only noninferior, but may also be superior to a longer duration (8 days or more). The secondary outcomes of the study include clinical parameters such as rate of acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization and days of antibiotics use. The study team will also characterise the microbiome changes in study participants according to the type and duration of antibiotics. MDROs collected will undergo whole genome sequencing for transmission dynamics study. The study is a multinational multicenter study involving hospitals in Asia. Funder: The project will beis partly joinly funded by Medical Research Council/ Department for International Development (MRC/DfID) and Singapore National Medical Research Council (NMRC/CTG). Grant Ref: MR/K006924/1 and MOH-000470 (MOH-CTGIIT18may-0003) Conclusions This is a randomised controlled hierarchical non-inferiority-superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations. Publication of this study https://pubmed.ncbi.nlm.nih.gov/33986070/

NCT ID: NCT03371186 Recruiting - Clinical trials for Reproductive, Maternal, Newborn, and Child Health

Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Start date: February 2016
Phase: N/A
Study type: Interventional

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.