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A clinical study to compare two techniques of pain relief(intravenous through blood route vs epidural through a catheter in back) after surgery for cancer treatment using reduction of tumour mass and chemotherapy at high temprature

ABSTRACT: Intervention1: Intravenous local anaesthetic and opioid infusion: Bolus dose of 1.5 mg/kg lignocaine over 15 mins, starting approximately 15 mins before surgical incision and fentanyl 0.5 mcg/kg, approximately 2 min before surgical incision will be administered. Following this patient will be receiving lignocaine infusion at 1 mg/kg/hr and fentanyl infusion at 0.5 mcg/kg/hr intraoperatively. Control Intervention1: Epidural Ropivacaine and fentanyl infusion: epidural catheter will be placed as per incision congruent technique before induction. Placement of the catheter will be checked by 3 ml of 2% lignocaine with adrenaline (1:200000). Epidural analgesia will be activated by 6 ml of Ropivacaine 0.2% and fentanyl (2 mcg/ml) approximately 15 min before surgical incision. Primary outcome(s): To evaluate postoperative analgesic efficacy of the analgesic technique.Timepoint: Immediately after extubation, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 18 hour and 24 hour. Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded

DISEASE(S): Malignant Neoplasm Of Rectum,Malignant Neoplasm Of Small Intestine,Malignant Neoplasm Of Stomach,Malignant Neoplasm Of Pancreas,Malignant Neoplasm Of Ovary,Malignant Neoplasm Of Colon

PROVIDER: 2597552 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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The Effect of Anaesthetic Drugs on Recovery in Patients Undergoing Cancer surgery

Project description:Intervention1: KETAMINE: Patients will be randomised to receive low dose ketamine infusions @ 0.1 mg/kg/hr + GA + Epidural; ketamine infusion will be started around the time of skin incision Intervention2: DEXMEDETOMIDINE: : Dexmedetomidine IV infusions @ 0.25 mcg/kg/hr + GA + Epidural; dexmedetomidine infusion will be started around the time of skin incision around the time of incision Control Intervention1: NORMAL SALINE: 0.9 % Saline IV infusions @ 5 ml/hr Primary outcome(s): 1.To assess the effect of infusion of a low dose of ketamine and dexmedetomidine infusions vs placebo on the time to passage of flatus in patients undergoing GI malignancy surgeries.Timepoint: Post - Operatively 24 hrs to 72 hrs Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded

| 2582579 | ecrin-mdr-crc

A clinical study to access safety and efficacy of TK-90 or parenteral TK-90 placebo in patients with colorectal cancer scheduled to receive bolus 5-fluorouracil and infused leucovorin.

Project description:Intervention1: Parenteral TK-90: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Control Intervention1: Parenteral TK-90 Placebo: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Placebo Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Primary outcome(s): A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (= Grade 2) without a subsequent instance of = Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.Timepoint: 48 Hr and 96 hr every week upto week 06 and at week 08 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded

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Effect of insulin infusion on human skeletal muscle

Project description:To identify insulin responsive genes in humans, in the first protocol, skeletal muscle biopsies from six non-diabetic subjects were obtained before and after a two-hour of hyperinsulinaemic (infusion rate 40 mU/m2/min) euglycemic clamp. A variable infusion of glucose (180 g/l) enriched with tritiated glucose (100 μCi/500 ml) maintained euglycemia during insulin infusion, with monitoring of plasma glucose concentration every 5 to 10 min during the basal and clamp periods using an automated glucose oxidation method (Glucose Analyzer 2, Beckman Instruments, Fullerton, CA). In the second protocol, skeletal muscle biopsies from six non-diabetic subjects were obtained before and after a 3-hour hyperinsulinemic (infusion rate 40 mU/m2/min) euglycemic clamp in order to increase the effects of insulin on gene expression. A variable infusion of glucose (180 g/l) was used to maintain euglycemia during insulin infusion with monitoring of plasma glucose concentration every 5 to 10 min using an automated glucose oxidation method (Glucose Analyzer 2, Beckman Instruments, Fullerton, CA). Keywords: dose response

2007-03-01 | GSE7146 | GEO

A study to compare two different modes of pain relief techniques (continuous delivery of Lidocaine (a pain killer) through the vein and epidural infusion(delivery of pain killer around the layers of spinal cord) in all patients undergoing keyhole surgery for colon cancer

Project description:Intervention1: Lidocaine: Administered intravenously as 2mg/kg bolus followed by infusion at 2mg/kg/hr from the start of surgery till 30 minutes after surgery Control Intervention1: Thoracic Epidural Analgesia: Thoracic Epidural Catheter is inserted at T8-T9 level through which 0.25% Bupivacaine with 1mcg/cc Fentanyl is administered as an infusion for 48 hours post operatively Primary outcome(s): Postoperative pain score at various intervals using Visual Analogue Score(VAS)Timepoint: 2,4,8,12,24 hours post operative

| 2582453 | ecrin-mdr-crc

Hypertensive Study

Project description:Animals. Male Sprague–Dawley rats (Charles River Laboratories, Wilmington, MA) weighing about 250g were used. The study was approved by the Thomas Jefferson University Institutional Animal Care and Use Committee and was conducted in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals. The animals were housed in Thomas Jefferson University's animal care facilities. Animals were anesthetized with isoflurane dissolved in O2 (5% induction; 1% maintenance) and one femoral artery and vein were cannulated (PE-50 tubing) via a small medial incision for measurement of arterial pressure and infusion of drugs, respectively. The cannulae were run subcutaneously to an exit incision between the scapulae. The leg wound was sutured and topical anesthetic (lidocaine) was applied to both skin incisions. Following surgery, after one hour of stable and normal resting blood pressure and heart rate, intravenous infusion was initiated of approximately 1 mL saline, as a control, or phenylephrine (200 µg/mL; 1 mL/hr), to induce hypertension. We followed standard methods in the use of phenylephrine (PE) to elevate blood pressure. PE does not cross the blood brain barrier and the elevated blood pressure it produces has been shown to cause molecular effects in the NTS principally via increased baroreceptor afferent drive by both pharmacological and sinoaortic denervation studies. We titered the PE dose to maintain intermediate levels of elevated blood pressure 25 mmHg above resting blood pressure. Keywords: Hypertension, time series

2007-12-01 | GSE8585 | GEO

Brief Hydrocortisone Infusion Differentially Influences Blood Leukocyte and Monocyte Gene Expression Before and After Endotoxin Administration in Humans (supported by NIH grant GM34695)

Project description:Fourteen human subjects (18-40 years of age) were studied. The control group (saline + LPS [n = 7]) received a 12 hour infusion of saline and the experimental group (cortisol + LPS [n = 7]) received a 12 hour infusion of cortisol (3 µg/kg/min). After 6 hours of saline or cortisol infusion, intravenous lipopolysaccharide (2 ng/kg) was administered to all subjects. Blood samples were collected at -24 hours, 0 hours, 6 hours and 24 hours relative to LPS administration at 0 hours. Leukocytes and monocytes were isolated from these blood samples, total RNA extracted, and microarray analyses performed using Affymetrix Focus GeneChips®.

2010-05-21 | GSE21909 | GEO

Effect of insulin infusion on human skeletal muscle

2007-03-01 | E-GEOD-7146 | biostudies-arrayexpress

A Novel Model of Common TLR4- and Injury induced transcriptional themes in Human Leukocytes (supported by NIH grant GM34695)

Project description:Fifteen human volunteer subjects (18-40 years of age) and 5 Trauma patients were studied. One volunteer group (saline + LPS [n = 8]) received a 12 hour infusion a second volunteer group (cortisol + LPS [n = 7]) received a 12 hour infusion of cortisol (3 µg/kg/min). After 6 hours of saline or cortisol infusion, intravenous lipopolysaccharide (2 ng/kg) was administered to all subjects. Blood samples were collected at 0 hours, 6 hours and 24 hours relative to LPS administration at 0 hours. Blood samples were drawn from a grounp of Trauma patients shortly (day1-5) after admission and later in their ICU stay (day 5-7). Leukocytes were isolated from these blood samples, total RNA extracted, and microarray analyses performed using Affymetrix Focus GeneChips® on samples yeilding sufficent quantity and quality RNA for analysis.

2010-06-11 | GSE22278 | GEO

Brief Hydrocortisone Infusion Differentially Influences Blood Leukocyte and Monocyte Gene Expression Before and After Endotoxin Administration in Humans (supported by NIH grant GM34695)

Project description:Fourteen human subjects (18-40 years of age) were studied. The control group (saline + LPS [n = 7]) received a 12 hour infusion of saline and the experimental group (cortisol + LPS [n = 7]) received a 12 hour infusion of cortisol (3 ug/kg/min). After 6 hours of saline or cortisol infusion, intravenous lipopolysaccharide (2 ng/kg) was administered to all subjects. Blood samples were collected at -24 hours, 0 hours, 6 hours and 24 hours relative to LPS administration at 0 hours. Leukocytes and monocytes were isolated from these blood samples, total RNA extracted, and microarray analyses performed using Affymetrix Focus GeneChips. Blood samples were collected at (-24)hr, 0hr, 6hr, and 24hr in relation to the LPS infusion. For both saline and cortisol treated subjects, infusion was started at (-6) hr and continued to (+6) hr.

2010-06-08 | E-GEOD-21909 | biostudies-arrayexpress

Examination of the MAPK pathway gene expression in patient samples

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