scholarly journals Effect of perioperative use of parecoxib on chronic post-surgical pain in elderly patients after hepatectomy: a prospective randomized controlled study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaodong Ge ◽  
Yan Pan ◽  
Danfeng Jin ◽  
Ying Wang ◽  
Shengjin Ge
Keyword(s):  
Placebo Group ◽  
Postoperative Complications ◽  
Elderly Patients ◽  
Acute Pain ◽  
Epidural Anesthesia ◽  
Inflammatory Markers ◽  
Controlled Study ◽  
Link Type ◽  
Surgical Pain ◽  
Chronic Post Surgical Pain

Abstract Background Chronic post-surgical pain (CPSP) has a negative impact on the recovery, quality of life, and physical functioning of elderly patients. This study aimed to test the superiority of parecoxib vs. placebo in preventing chronic post-hepatectomy pain in elderly patients under combined general-epidural anesthesia. Methods A total of 105 elderly patients undergoing hepatectomy under combined general-epidural anesthesia were randomized into the parecoxib or placebo group. The primary outcome was the proportion of patients with CPSP 3 months postoperatively. The secondary outcomes included the Short-Form McGill Pain Questionnaire score in CPSP-positive responders, acute pain intensity, postoperative analgesic demand, inflammatory markers change, and postoperative complications within 28 days. Results The parecoxib group provided a non-significant absolute 9.1% reduction in the rate of CPSP compared to the placebo group (P = 0.34). The average chronic pain visual analog scale in the parecoxib group was lower than that in the placebo group (P = 0.04). Significantly less moderate-to-severe acute pain at rest (P = 0.04) and with coughing (P < 0.001), less patient-controlled epidural analgesia (PCEA) consumption (P = 0.01), and less rescue analgesia (P < 0.001) were observed in the parecoxib group compared to the placebo group. Furthermore, no between-group difference was observed in inflammatory markers (P > 0.05) and postoperative complications (P = 0.65). Conclusions Parecoxib reduced the prevalence of CPSP in elderly patients after hepatectomy under combined general-epidural anesthesia from 44.4 to 35.3% with no statistical significance. Moreover, significantly alleviated CPSP intensity and improved acute pain management were observed. Trial registration This study was retrospectively registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn/edit.aspx?pid=56961&htm=4) on August 3, 2020 (ChiCTR-2,000,035,198).

scholarly journals Impact of Perioperative Use of Parecoxib on Chronic Postsurgical Pain in Elderly Patients Undergoing Hepatectomy: A Prospective Randomized Controlled Study

2021 ◽  
Author(s):  
Xiaodong Ge ◽  
Yan Pan ◽  
Danfeng Jin ◽  
Ying Wang ◽  
Shengjin Ge
Keyword(s):  
Placebo Group ◽  
Postoperative Complications ◽  
Elderly Patients ◽  
Epidural Analgesia ◽  
Acute Pain ◽  
Epidural Anesthesia ◽  
Inflammatory Markers ◽  
Controlled Study ◽  
Postsurgical Pain ◽  
Chronic Postsurgical Pain

Abstract Background Chronic postsurgical pain (CPSP) in elderly patients negatively impacts recovery, quality of life, and physical functioning. This study aimed to test parecoxib's superiority versus placebo in combination with epidural anesthesia in preventing chronic post-hepatectomy pain in elderly patients.Methods One hundred and five elderly patients undergoing hepatectomy were randomized to the parecoxib group or placebo group combined with epidural anesthesia. The primary outcome was the proportion of patients with CPSP at postoperative three months. The secondary outcomes included the Short-Form McGill Pain Questionnaire score in CPSP-positive responders, acute pain intensity, postoperative analgesic demand, inflammatory markers change, and postoperative complications within 28 days. Results The parecoxib group provided a non-significant absolute 9.1% reduction in the rate of CPSP compared with the placebo group (35.3% vs. 44.4%, P=0.34). The average chronic pain verbal analog scale in the parecoxib group was lower than that in the placebo group (median (IQR) 2(1, 2) vs. 3 (2, 3), P=0.04). Significantly less moderate-to-severe acute pain at rest (4.3% vs. 17.3%, P=0.04) and with coughing (32.6% vs. 73.1%, P<0.001), less patient-controlled epidural analgesia (PCEA) consumption ( 197.4±43.6mL vs. 219.2±42.4mL, P=0.01) and less rescue analgesia (median (IQR) 0 (0, 0) vs. 1 (0, 2), P<0.001) were observed in parecoxib group. Furthermore, there was no between-group difference in inflammatory markers (P>0.05) and postoperative complications (11.8% vs.14.8%, P=0.65).Conclusions Parecoxib reduced the prevalence of CPSP in elderly patients undergoing hepatectomy under epidural analgesia from 44.4% to 35.3% with no statistical significance. Meanwhile, significantly alleviated CPSP intensity and improved acute pain management were observed.Trial Registration This study was retrospectively registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn/edit.aspx?pid=56961&htm=4) on August 3, 2020 (ChiCTR-2000035198).

scholarly journals Dexamethasone blunts postspinal hypotension in geriatric patients undergoing orthopedic surgery: a double blind, placebo-controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tarek M. Ashoor ◽  
Noha S. Hussien ◽  
Sherif G. Anis ◽  
Ibrahim M. Esmat
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Elderly Patients ◽  
Spinal Anesthesia ◽  
Demographic Data ◽  
Volume Overload ◽  
Controlled Study ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Link Type

Abstract Background Post-spinal anesthesia (PSA) hypotension in elderly patients is challenging. Correction of PSA hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Dexamethasone is used to treat conditions manifested by decrease of peripheral vascular resistance. The research team was the first to test the hypothesis of its role in preventing or decreasing the incidence of PSA hypotension. Methods One hundred ten patients, aged 60 years or more were recruited to receive a single preoperative dose of dexamethasone 8 mg IVI in 100 ml normal saline (D group) (55 patients) 2 h preoperatively, and 55 patients were given placebo (C group) in a randomized, double-blind trial. Variations in blood pressure and heart rate in addition to the needs of ephedrine and/or atropine following spinal anesthesia (SA) were recorded. SA was achieved using subarachnoid injection of 3 ml hyperbaric bupivacaine 0.5%. Results Demographic data and the quality of sensory and motor block were comparable between groups. At 5th, 10th minutes post SA; systolic, diastolic and mean arterial pressures were statistically significant higher in D group. At 20th minutes post SA; the obtained blood pressure readings and heart rate changes didn’t show any statistically significance between groups. The need for ephedrine and side effects were statistically significant lower in D group than C group. Conclusion Post-spinal anesthesia hypotension, nausea, vomiting and shivering in elderly patients were less common after receiving a single preoperative dose of dexamethasone 8 mg IVI than control. Registration number ClinicalTrials.gov Identifier: NCT 03664037, Registered 17 September 2018 - Retrospectively registered, http://www.ClinicalTrial.gov

scholarly journals Effects of Preoperative Carbohydrate Intake on Inflammatory Markers and Clinical Outcomes in Elderly Patients Undergoing Radical Prostatectomy: A Single-Centre, Double-Blind Randomised Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhen Hu ◽  
Ji Liu ◽  
Fen Wang
Keyword(s):  
Drinking Water ◽  
Placebo Group ◽  
Radical Prostatectomy ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Open Radical Prostatectomy

Background: This study aimed to analyse the effects of carbohydrate (CHO) intake on inflammatory markers, comfort, and clinical outcomes in elderly patients undergoing open radical prostatectomy.Methods: Patients aged ≥65 years who underwent open radical prostatectomy were randomly divided into CHO, drinking water, and fasting groups. A total of 90 patients were enrolled in this study (CHO group, n = 28; placebo group, n = 30 and fasting group, n = 32). Patients in the CHO group were given 800 and 400 ml of carbohydrates 8 and 2–3 h before surgery, respectively. Patients in the placebo group were given 800 and 400 ml of water 8 and 2–3 h before surgery, respectively. Patients in the fasting group did not consume any liquids. The main result is levels of inflammation markers. Secondary results included cellular immunity, comfort, body weight, grip index, and clinical results.Results: Compared with the fasting group, the CHO group exhibited a decrease in interleukin 6 (IL-6) levels on days 1 and 7 (75.47 and 7.06 pg/mL, respectively), IL-8 levels on day 1 (274.61 pg/mL) and tumour necrosis factor (TNF) levels on days 1, 3, and 7 (11.16, 9.55, and 9.67 pg/mL, respectively). The placebo group exhibited a decrease in IL-8 (390.26 pg/mL) and TNF levels (13.99 pg/mL) on day 1. Compared with the placebo group, the CHO group exhibited a decrease in IL-6 levels on day 1 and TNF levels on day 3. In the CHO and placebo groups, the thirst and hunger scores decreased on the morning of surgery.Conclusion: Preoperative CHO and drinking water are associated with decreased levels of IL-6, IL-8, and TNF. CHO and water can also reduce thirst and hunger scores. Therefore, we recommend that patients without contraindications should be given 200–400 ml of fluid 2–3 h before surgery, preferably CHO.Clinical Trial Registration:http://www.chictr.org.cn/edit.aspx?pid=21783&amp;htm=4; ChiCTR-INR-17012867.

scholarly journals Curcuma longa extract improves serum inflammatory markers and mental health in healthy participants who are overweight: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Ryusei Uchio ◽  
Kengo Kawasaki ◽  
Chinatsu Okuda-Hanafusa ◽  
Ryosuke Saji ◽  
Koutarou Muroyama ◽  
...  
Keyword(s):  
Mental Health ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Curcuma Longa ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Sf 36 ◽  
Anti Inflammatory ◽  
Serum Inflammatory Markers

Abstract Background The dietary spice Curcuma longa, also known as turmeric, has various biological effects. Both a water extract and a supercritical carbon dioxide extract of C. longa showed anti-inflammatory activities in animal studies. However, the anti-inflammatory effect in humans of a mixture of these two C. longa extracts (CLE) is poorly understood. Therefore, we investigated the effect of CLE containing anti-inflammatory turmeronols on chronic inflammation and general health. Methods We performed a randomized, double-blind, placebo-controlled study in healthy subjects aged 50 to 69 years with overweight. Participants took two capsules containing CLE (CLE group, n = 45) or two placebo capsules (placebo group, n = 45) daily for 12 weeks, and serum inflammatory markers were measured. Participants also completed two questionnaires: the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS) scale. Treatment effects were analyzed by two way analysis of variance followed by a t test (significance level, p <  0.05). Results After the intervention, the CLE group had a significantly lower body weight (p <  0.05) and body mass index (p < 0.05) than the placebo group and significantly lower serum levels of C-reactive protein (p < 0.05) and complement component 3 (p < 0.05). In addition, the CLE group showed significant improvement of the MOS SF-36 mental health score (p < 0.05) and POMS anger-hostility score (p < 0.05). Conclusion CLE may ameliorate chronic low-grade inflammation and thus help to improve mental health and mood disturbance. Trial registration UMIN-CTR, UMIN000037370. Registered 14 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042607

Abstract 4420: Results of A Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of PS433540 in Human Subjects with Hypertension

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Joel M Neutel ◽  
Wilford F Germino ◽  
Henry Punzi ◽  
Mark McBride ◽  
Catherine C Bryson ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Human Subjects ◽  
Antihypertensive Agents ◽  
Epidemiologic Studies ◽  
Controlled Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type

Epidemiologic studies continue to demonstrate extremely disappointing blood pressure (BP) control rates. For this reason, the search for more effective antihypertensive agents continues. PS433540 is the first compound in a novel class of agents called Dual Acting Receptor Antagonists (DARA) which selectively block angiotensin (AT 1 ) and endothelin (ET A ) receptors. In this prospective, randomized, double blind, placebo controlled study, 234 men and women with a mean age of 56.0 years entered a 3– 4 week single blind placebo run-in period. Qualifying stage I or stage II hypertensive patients were randomized in a 1:1:1 ratio to either PS433540 200mg, 500mg or matching placebo for a period of 4 weeks. Ambulatory BP monitoring (ABPM) was performed at the start of the study and was repeated at the end of the treatment period. PS433540 lowered both 24HR Systolic BP (SBP) and Diastolic DBP (DBP) as well as mean office SBP and DBP to a greater extent than placebo, p<0.001. (see Table ) PS433540 was well tolerated with 2 reported serious adverse events in the placebo group and placebo lead-in period. Three patients (all from the placebo group) were discontinued from the study for adverse events. There were no significant laboratory abnormalities. This study demonstrates that PS433540 is an effective and well tolerated new class of antihypertensive agent that may prove to be a very important addition to our armamentarium for the management of hypertension.

scholarly journals Effects of GH on cognitive function in elderly patients with adult-onset GH deficiency: a placebo-controlled 12-month study

2007 ◽  
Vol 156 (4) ◽  
pp. 439-447 ◽  
Author(s):  
Mahesh Sathiavageeswaran ◽  
Pia Burman ◽  
David Lawrence ◽  
Alan G Harris ◽  
Marina G Falleti ◽  
...  
Keyword(s):  
Placebo Group ◽  
Cognitive Function ◽  
Elderly Patients ◽  
Gh Deficiency ◽  
Treated Group ◽  
Controlled Study ◽  
Examination System ◽  
Gh Therapy ◽  
Double Blind ◽  
Igf I

Objective: Young adults with childhood-onset GH deficiency (GHD) have reduced memory and attention, which can be improved by treatment with GH. Little information is available on cognitive function in elderly GHD patients. Design: Single center, double-blind, randomized, placebo-controlled study of 52-week duration. Methods: Elderly GH therapy naïve GHD patients (n=34; age range 60–77 years) were enrolled and randomized to receive placebo or GH therapy which was titrated to achieve a target IGF-I level of +1 to +2 s.d. of the normal mean for age. Cognitive function was assessed at baseline and after 24 and 52 weeks, using a computerized psychometric test package (Neurobehavioral Examination System-2). Results: The mean GH dose was 0.16±0.06 mg/day; mean IGF-I increased from 135±59 ng/ml at baseline to 213±77 ng/ml during active treatment. The GH-treated group had better mean serial digit learning scores compared with placebo group (P<0.05). Assessment of effect sizes showed that improvements in memory occurred with GH after 24 weeks. The overall adverse event rates were similar in the GH and the placebo group. Conclusion: This study indicates that GH replacement may be accompanied by improvement in certain measures of cognitive function in elderly patients with GHD.

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