scholarly journals RANDOMISED CONTROLLED STUDY TO EVALUATE THE EFFECTS OF NITROGLYCERINE SUBLINGUAL SPRAY ON TRACHEAL EXTUBATION RESPONSE IN NORMOTENSIVE PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA

2020 ◽  
pp. 1-6
Author(s):  
Surendra Kumar Raikwar ◽  
Anil Kori* ◽  
Aditya Agarwal
Keyword(s):  
Stress Response ◽  
General Anaesthesia ◽  
Tracheal Extubation ◽  
Controlled Study ◽  
Control Group ◽  
Pain Anxiety ◽  
Arterial Blood ◽  
Variable Success ◽  
Related Stress ◽  
Randomised Controlled

Tracheal extubation is the translaryngeal removal of a tube from the trachea via the nose or mouth and associated with awakening, pain, anxiety, airway irritation which may cause a cough or difculties in breathing and may contribute to an increase in haemodynamic response (1) .Several modalities, both pharmacological and nonpharmacological have been tried to decrease this stress response with variable success. We undertook this study to assess the efcacy of NTG spray in decreasing extubation related stress response in normotensive patients undergoing elective surgeries under general anaesthesia. Material and methods : Sixty normotensive patients were included in study and randomly subdivided into two groups of 30 patients each – group N receiving NTG spray and Group C not receiving NTG spray prior to extubation. Hemodynamic stress response during extubation was noted in both the groups and compared. Result and conclusion : Extubation was associated with signicant rise in systolic, diastolic and mean arterial blood pressure and heart rate in both the groups, but this stress response was signicantly less in NTG Group as compared to control group.

scholarly journals Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m4284 ◽  
Author(s):  
Hartmuth Nowak ◽  
Nina Zech ◽  
Sven Asmussen ◽  
Tim Rahmel ◽  
Michael Tryba ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Confidence Interval ◽  
General Anaesthesia ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Number Needed To Treat ◽  
Opioid Use ◽  
Number Of Patients ◽  
Randomised Controlled

Abstract Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use. Design Blinded randomised controlled study. Setting Five tertiary care hospitals in Germany. Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group. Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape. Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain). Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported. Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery. Trial registration German Clinical Trial Register DRKS00013800.

scholarly journals The effect of preoperative aminophylline on the recovery profile after major pelvic-abdominal surgeries: a randomized controlled double-blinded study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Samaa A. Kasim ◽  
Mahmoud Hussein Bahr ◽  
Mohamed Abdelkader ◽  
Doaa Abu Elkassim Rashwan
Keyword(s):  
General Anaesthesia ◽  
Demographic Data ◽  
Tracheal Extubation ◽  
Trial Registration ◽  
Control Group ◽  
P Value ◽  
Clinical Trial Registration ◽  
Arterial Blood ◽  
Recovery Profile ◽  
Extubation Time

Abstract Background This study compared the effects of premedication with different doses of aminophylline on the recovery profile after general anaesthesia. Methods Forty-five patients scheduled for pelvic-abdominal surgeries were divided into 3 groups: Group C: the patients received 100 ml of IV normal saline, Group A1: the patients received 2 mg/kg IV aminophylline, and Group A2: the patients received 4 mg/kg IV aminophylline 30 min before induction of general anaesthesia. The following data were recorded: demographic data, ASA physical status, duration of anaesthesia and surgery, heart rate, mean arterial blood pressure, propofol dose, fentanyl dose, times to reach BIS (48 ± 2) after induction of anaesthesia and to reach a value of 80 after discontinuation of sevoflurane anaesthesia, time to recovery of consciousness and to tracheal extubation and to discharge from the post-anaesthesia care unit, and side effects of aminophylline. Results The time to reach a BIS of 48 ± 2 was significantly lower for the control group than group A2 (70.67 ± 22.50 and 106.67 ± 34.77 s for groups C and A2, respectively, p -value =0.01). The time to reach a BIS of 80 was significantly longer for the control group than group A1 andA2 (5.6 ± 1.40,3.5 ± 1.93and 2.53 ± 1.72 min for groups C,A1 and A2, respectively, p -value < 0.01). The time to ROC was significantly longer for the control group than groups A1 and A2 (8.93 ± 0.92, 5.6 ± 2.47 and 4.53 ± 3.33 min for groups C, A1 and A2, respectively; p -value < 0.01). The extubation time was significantly longer for the control group than groups A1 and A2 (12.4 ± 1.08, 7.87 ± 3.27 and 6.6 ± 2.47 min for groups C, A1 and A2, respectively; p -value < 0.01). Conclusion Premedication with aminophylline enhanced the recovery profile after pelvic-abdominal surgeries under general anaesthesia without cardiovascular complications. Clinical trial registration Name of the registry: [email protected] Trial registration number: ClinicalTrials.gov Identifier: NCT04151381. Date of registration, November 5, 2019, ‘Retrospectively registered’.

Effect of adjunctive sodium hyaluronate versus surfactant nasal irrigation on mucociliary clearance in allergic rhinitis: a single-blind, randomised, controlled study

2021 ◽  
pp. 1-4
Author(s):  
E Ocak ◽  
S Mulazimoglu ◽  
D Kocaoz ◽  
E Mirici ◽  
E Dagli ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Mucociliary Clearance ◽  
Isotonic Saline ◽  
Sodium Hyaluronate ◽  
Controlled Study ◽  
Control Group ◽  
Clearance Time ◽  
Nasal Irrigation ◽  
Persistent Allergic Rhinitis ◽  
Randomised Controlled

Abstract Objective To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. Methods A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. Results Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). Conclusion Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.

scholarly journals Analgesic effects of intravenous flunixin and intrafunicular lidocaine or their combination for castration of lambs

2018 ◽  
Vol 5 (1) ◽  
pp. e000266 ◽  
Author(s):  
Paola Straticò ◽  
Vincenzo Varasano ◽  
Riccardo Suriano ◽  
Massimo Mariscoli ◽  
Domenico Robbe ◽  
...  
Keyword(s):  
General Anaesthesia ◽  
Controlled Trial ◽  
Serum Cortisol ◽  
Cortisol Concentration ◽  
University Teaching ◽  
Control Group ◽  
Lidocaine Group ◽  
Analgesic Effects ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo analyse the effectiveness of intrafunicular lidocaine and intravenous flunixin for reducing pain and signs of stress in lambs undergoing surgical castration.DesignRandomised controlled trial.SettingOne university teaching hospital in Italy.Participants30 healthy male lambs, 9–12 weeks old.InterventionAllocation to five groups: a control group (C), undergoing general anaesthesia but not castration; a surgery group (S), undergoing orchiectomy without analgesic treatment; a surgery-lidocaine group (SL), undergoing orchiectomy and receiving intrafunicular 2 per cent lidocaine solution; a surgery-flunixin group (SF), undergoing orchiectomy and receiving intravenous flunixin; a surgery-flunixin-lidocaine group (SFL), undergoing orchiectomy and receiving both intrafunicular lidocaine and intravenous flunixin.Main outcome measuresNociception and stress were assessed through intraoperative indicators, serum cortisol concentration, glycaemia, behaviour, immune response and clinical evaluation of the heart rate (HR), respiratory rate and rectal temperature after surgery.ResultsGroups S and SL showed increased values of intraoperative HR, mean arterial pressure and postoperative cortisol concentration. In group SFL, cortisol values were similar to those of group C. No other difference could be detected.ConclusionsThe combination of intravenous flunixin and intrafunicular lidocaine reduced the pain and discomfort of lambs castrated under general anaesthesia. Intrafunicular lidocaine alone did not prevent pain or discomfort associated with castration.Trial registration number30/2012/CEISA/COM.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Effects of Ketamine Gargle for Post-operative Sore Throat, Hoarseness of Voice and Cough Under General Anaesthesia- A Randomised Control Study

2021 ◽  
Author(s):  
Dinesh Chauhan ◽  
Ankit Mankad ◽  
Jigisha Mehta ◽  
Tejash H Sharma
Keyword(s):  
General Anaesthesia ◽  
Endotracheal Intubation ◽  
Normal Saline ◽  
Healing Process ◽  
Voice Quality ◽  
Controlled Study ◽  
P Value ◽  
Time Duration ◽  
C 30 ◽  
Randomised Controlled

Introduction: Majority of the patient undergo endotracheal intubation for various time duration, when given general anaesthesia. Injury in airway mucosa or vocal cords due to endotracheal intubation can be a contributing factor. Ketamine without affecting local healing process has an anti-proinflammatory effect as it limits exacerbation of systemic inflammation. Aim: To study the role of ketamine gargles as a pharmacological measure in order to attenuate POST, HOV and cough followed by endotracheal intubation during surgeries under general anaesthesia. Materials and Methods: A randomised controlled study was carried out for a duration of 22 months from the institutional ethical committee (Study Approval No. SVIEC/ON/MEDI/BNPG18/D19046), on 50 patients of American Society of Anaesthesiologists (ASA) grade I and II. They were allocated into two groups of 25 patients. Group (K): ketamine 50 mg in 29 mL 0.9% normal saline and Group (C): 30 mL 0.9% normal saline. Patients were advised to gargle for 30 seconds just 5 minutes prior to induction of anaesthesia. Patients were intubated with appropriate size of the endotracheal tube and were extubated when fully awake and conscious. Pateints were shifted to postoperative ward and were kept in propped up position with oxygen. Pateints were assessed at 1,2,4,24 hours for incidence of POST, HOV and cough. Assessment was made as per the 4 point scale grading system. The statistical analysis was performed using unpaired t-test, p<0.05 considered statistically significant. Results: In terms of POST grading in both K and C groups p-value was statistically significant (p<0.05) at 1 and at 2 hours postoperatively. In terms of HOV, in group K voice quality issues were reduced till 24 hours, (p<0.05). In terms of cough, in group K there was a significant reduction in complaints of cough till 4 hours postoperatively, (p<0.05). Conclusion: Ketamine gargles is effective in attenuating POST and cough till 2 hours and HOV till 4 hours postoperatively in patients following endotracheal intubation.

scholarly journals Effects of weekly pain monitoring on back pain outcomes: a non-randomised controlled study

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Alice Kongsted ◽  
Tue Secher Jensen ◽  
Klaus Doktor ◽  
Lise Hestbæk
Keyword(s):  
Back Pain ◽  
Pain Intensity ◽  
Activity Limitation ◽  
Controlled Study ◽  
Group Differences ◽  
Control Group ◽  
Negative Effects ◽  
Randomised Controlled Study ◽  
Pain Outcomes ◽  
Randomised Controlled

Abstract Background Disease monitoring is an important element of self-management of several chronic diseases. Pain monitoring has become very easily available, but the role in musculoskeletal pain conditions is not clear. Awareness of pain might be helpful for people to understand pain, but focusing on pain may on the contrary negatively affect pain experience and behaviours. The objective of this study was to investigate the potential impact of pain monitoring on low back pain (LBP), specifically to determine if pain intensity, activity limitation and pain control, differed between patients with weekly pain monitoring over 12 months and patients with follow-ups at 2 weeks, 3 months and 12 months. Methods This was a non-randomised controlled study embedded in a cohort study with data collection November 1st 2016 to December 21st 2018. Adults seeking care for LBP were enrolled at the first visit to a chiropractor and followed with surveys after 2 weeks, 3 months and 12 months. Those enrolled first, n = 1,623, furthermore received weekly SMS-questions about pain frequency and pain intensity, whereas those enrolled next was the control group, n = 1,269 followed only by surveys. Outcomes at 12-months were compared, adjusting for group differences on baseline parameters. Results LBP intensity (0–10) was slightly lower at 12-months follow-up in the SMS group than the control group (adjusted beta − 0.40 (95% CI: − 0.62; − 0.19)). No relevant between-group differences were observed for activity limitation (0–100) (1.51 (95% CI: − 0.83; 3.85)) or ability to control pain (0–10) (− 0.08 (95% CI − 0.31; 0.15)). Conclusions Frequent pain monitoring did not demonstrate any negative effects of weekly pain monitoring, and it was perhaps even helpful. The role of self-monitoring as part of self-managing LBP should be explored further including optimal frequencies, formats, and methods for feedback. Trial registration The study was not registered as a clinical trial.

Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

2012 ◽  
Vol 108 (11) ◽  
pp. 913-922 ◽  
Author(s):  
Uri Martinowitz ◽  
Jerzy Windyga ◽  
Giovanni Di Minno ◽  
Andrzej Hellmann ◽  
Ingrid Pabinger ◽  
...  
Keyword(s):  
Controlled Study ◽  
Control Group ◽  
Investigational Drug ◽  
Haemophilia A ◽  
Double Blind ◽  
Investigational Treatment ◽  
Joint Health ◽  
Secondary Endpoints ◽  
Recombinant Fviii ◽  
Randomised Controlled

SummaryThe benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79–4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79–4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79–4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79–4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79–4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79–4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79–4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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