CenterWatch
  • Search Clinical Trials
  • Clinical Trial Listings
  • Volunteer
  • Learn About Clinical Trials

Bry Sur Marne Cedex, France

< 2 Miles
Filters

Type

Distance
Age
0
0
Gender
Trial Phase
Sponsor
  • Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

    Phase

    4

    Span

    61 weeks

    Sponsor

    Damanhour Teaching Hospital

    Recruiting

  • Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

    A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

    Phase

    4

    Span

    54 weeks

    Sponsor

    Second Affiliated Hospital of Wenzhou Medical University

    Recruiting

    Healthy Volunteers

  • Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children

    Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children. Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children. This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.

    Phase

    4

    Span

    57 weeks

    Sponsor

    Fujian Provincial Hospital

    Recruiting

  • The Effect of Premedication on Postoperative Pain and Anxiety in Breast Cancer Surgery

    In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety

    Phase

    N/A

    Span

    16 weeks

    Sponsor

    Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Recruiting

    Healthy Volunteers

  • Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy

    Steroids are used routinely aiming to reduce pain and nausea, especially in surgery with high levels of postoperative pain. The majority of international studies on tonsillectomy (TE) are performed on dexamethasone which is used in large parts of the world. Use of steroids when TE is performed on children are also more studied on than on adults. Islam et al 2011 demonstrated in a study that dexamethasone (8 mg) reduced postoperative nausea for 24 hours in a study population of both children and adults. Mc Kean et al 2006 studied the effect of 10 mg dexamethasone on nausea in adults after TE during a seven-day period. Effect was seen during the first 24 hours but not the remaining days. With regard to postoperative pain, the research results differ in terms of what effect steroids have at TE. Mc Kean et al 2006 showed significantly lower estimated pain on surgery day and day 4 to 7 after a single dose of dexamethasone peroperatively. Stewart et al 2002 has shown that, by means of preoperatively given dexamethasone (8 mg) and in decreasing dose over an 8 day period postoperative [2mgx2 for 4 days and then 2mgx1 for 4 days], the patient's estimated pain and consumption of additional pain relievers were reduced. Michele et al 1999, on the other hand, found no effect on pain over a 10 day period despite a relatively high peroperatively dose of dexamethasone (20 mg). There are, however, studies on children, suggesting that there is a dose-dependent relationship between dexamethasone and postoperative bleeding after TE in children. In a study by Czarnetzki et al 2008, 0.05, 0.15 and 0.5 mg / kg dexamethasone were used peroperatively. In this study it was seen that 0.5 mg / kg dexamethasone increased the risk of bleeding from 4% to 24%, which led to a premature termination of the study due to the bleeding risk. In 2012, a meta-analysis of the steroid effect on bleeding after tonsillectomy was conducted by Plante et al. Both studies on children and adults were included. No significant increase in the overall frequency of bleeding after tonsillectomy was seen. On the other hand, a significant increase in the number of haemorrhages that required operative action was noted. This could be interpreted as that the severity of bleedings was increased. It was recommended that systemic steroids should be used with caution until further studies have been performed. The investigators conducted a retrospective study on children with TE in Gällivare with and without betamethasone (69 patients in total) and found no evidence of increased bleeding risk, but also no effect on PONV. However, a significant effect on pain was found during the first 24 hours postoperative with the average dose of 0.15 mg / kg. When comparing different cortisone preparations, 8 mg of betamethasone corresponds to approximately 10 mg of dexamethasone. Bellis et al., 2014 performed a meta-analysis of dexamethasone and postoperative bleeding at TE in children, but considered that more studies are needed to determine the bleeding risk before any safe conclusions can be drawn. Thus, there are uncertainties with regard to the cortisone effect, both when it comes to the size of the dose and whether there really is an effect on PONV and / or postoperative pain or not. On the other hand one does not want to use high doses with risks of postoperative bleeding. Betamethasone has not been studied to the same extent as dexamethasone, and in Sweden betamethasone is preferably used preoperatively to counteract PONV and pain associated with certain operations. The results of previous studies are however not conclusive and there is no consensus of what doses that should be used. In Sweden 4 mg of betamethasone, given intravenously during the surgery, is routine at tonsillectomy surgery. However, in the literature there is very weak evidence that such a small dose have any effect. On the other hand, there are studies signaling that dexamethasone doses of 20 mg (= 16 mg betamethasone) reduced PONV, but increased postoperative hemorrhages after TE surgery. Glucocorticoids may act via the following mechanisms: (1) anti-inflammatory effect; (2) direct central action at the solitary tract nucleus, (3) interaction with the neurotransmitter serotonin, and receptor proteins tachykinin NK1 and NK2, alpha-adrenaline, etc.; (4) maintaining the normal physiological functions of organs and systems; (5) regulation of the hypothalamic-pituitary-adrenal axis; and (6) reducing pain and the concomitant use of opioids, which in turn reduces opioid-related nausea and vomiting. 2.2. Risk/Benefit evaluation One of the main problems after tonsillectomy is PONV and especially postoperative pain that can persist up to 10-14 days after the surgery. This long period of postoperative pain leads to weakness and dehydration due to difficulties to eat and drink after the operation. Sometimes hemorrhage after TE can be fatal, but normally the bleeding can be stopped with local anaesthesia or diathermy during general anaesthesia. Normally this type of bleeding occurs in 8-10% after TE. After TE the patients normally go home the same day as the surgery. In northern Sweden the distances from the Hospital with an ear, nose and throat (ENT) emergency unit to the home of the patients could be as far as 3-400 kilometers. In this situation it is not advisory to give additional medications, which increases the risk of lethal hemorrhage. Benefits of 8 mg betamethasone: - Reduced PONV - Reduced pain => Less NSAID pain killers => Less risk of hemorrhage - Reduced pain => Increased ability to eat and drink => less risk of postoperative infection => less risk of bleeding - Reduced pain => Shorter sick leave => Socioeconomic benefits Risks of 8 mg betamethasone: - Increased bleeding risk => more patients comes back to the hospital due to hemorrhage => more patients need re-surgery with diathermy of the bleeding - Patients with gastric ulcers have an increased risk of gastric bleeding A previous retrospective study showed a reduced pain postoperatively with 8 mg betamethasone, without any sign of increased postoperative hemorrhage. There are no studies that have showed an increased postoperative risk of hemorrhage with 10 mg of dexamethasone given to adults at TE surgery. On the other hand lower doses of dexamethasone, as for example 5 mg (= 4 mg of betamethasone), does not seem to have any clinical benefits. The aim of the present study is to evaluate if it is possible to register a beneficial effect of 8 mg betamethasone, given as a premedication orally, without increasing side effects as increased bleeding. In conclusion, the side effects are mild and probably very infrequent, while the positive effects are visible in almost all patients with less pain and a shorter recovery period after the surgery. 3. STUDY OBJECTIVES AND ENDPOINTS 3.1. Primary objective The primary objective of this study is to verify if 8 mg of betamethasone at adolescents and adult TE operations can significantly reduce PONV. 3.2. Secondary objective(s) The secondary objective is to verify that 8 mg of betamethasone in adolescents and adult TE operations reduces postoperative pain but does not increase the postoperative bleeding risks. 4. STUDY DESIGN AND PROCEDURES 4.1. Overall study design and flow chart The study is a double-blind, placebo-controlled, randomized study in 100 volunteered patients over 12 years of age selected for elective tonsillectomy at the ENT clinic in Norrbotten. Patients fulfilling all of the inclusion and none of the exclusion criterias will be included. Enrollment will be continued until the required sample size is achieved (100 subjects). Once informed consent is obtained, screening data will be collected to determine each subject´s eligibility for study participation. The total expected duration of the subject participation is maximum 95 days, from screening visit to end of follow-up. The active participation is 5 days (surgery at visit 2 and phone calls, 1 and 5 days after day of surgery). The study pharmaceutical (betamethasone) is a well-known substance and has been used in humans for many years for the same indications as in the present study. Thus it will be regarded as a phase IV study.

    Phase

    4

    Span

    327 weeks

    Sponsor

    Umeå University

    Recruiting

  • Efficacy of Ivabradine Versus Propranolol Premedication During Hypotensive Anesthesia in Endoscopic Sinus Surgery

    Aim of the work To compare efficacy of oral premedication with ivabradine versus propranolol before hypotensive anesthesia with nitroglycerin during endoscopic sinus surgery on reduction of reflex tachycardia. Secondary aim: - Compare the safety and incidence of side effects between both drugs. - Compare the amount of nitroglycerin used, and blood loss between both drugs during endoscopic sinus surgery. Patients and methods This study will be conducted in the Department of Anesthesia, ENT operating theater, Alexandria University Hospitals after being approved by the Departmental Research and Ethical Committee, and after obtaining informed consents from all patients. 50 Patients, aged from 18 to 39 years, ASA physical status I and II, undergoing endoscopic sinus surgery will be enrolled in the study. Exclusion Criteria: - Patients with cardiovascular disease (hypertension, congestive heart failure, and coronary artery disease). - Patients on beta-blockers. - Patients with the base line heart rate<60 beats per minute. - Patients with diabetes mellitus (DM). - Cerebrovascular insufficiency. - Coagulation defects. - History of renal or hepatic insufficiency. - Hypersensitivity to the study drugs. - Patients with history of bronchial asthma The patients will be randomly allocated by simple randomization using a computer programme into two groups by closed envelope technique (having 25 patients in each group): GROUP (P): will receive oral propranolol (INDERAL® -propranolol hydrochloride Ph. Eur. 10mg manufactured by AstraZeneca Egypt under license of AstraZeneca UK), 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia. GROUP (I): will receive oral ivabradine (Procoralan® 5mg manufactured by Servier laboratories, France), 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia. Preoperative screening of all patients will include: 1. Demographic data (age, sex). 2. Detailed medical history. 3. Complete physical examination. 4. Routine laboratory investigations: - Complete blood picture. - Bleeding time and coagulation time. - Prothrombin time and activated partial thromboplastin time. - Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST). - Serum bilirubin (total and direct). - Blood urea and serum creatinine. - Fasting blood sugar. 5. Chest X-ray. 6. Standard 12 leads electrocardiogram. Anesthesia: • All patients will receive the same anesthetic technique. - Premedication will be standardized for all patients and consists of oral diazepam 5 mg the night before surgery. - On arrival to operating room, intravenous line will be cited and lactated ringer solution will be infused 4-6 ml/kg/h. - Before induction of general anesthesia (GA), all patients will be monitored with: - None-invasive blood pressure (NIBP). - Electrocardiograph (ECG). - Pulse oximeter (SpO2). - After induction of GA, all patients will be monitored with: - Capnography for end-tidal CO2 (ETCO2). - Radial artery cannula (G20) for intra-arterial blood pressure monitoring after performing Allen's test. - Peripheral nerve stimulator (PNS) will be applied on the ulnar nerve for neuromuscular blockade. Induction and maintenance of anesthesia: - Anesthesia Will be induced with propofol 2mg/kg iv, fentanyl 1 μg/kg iv and cisatracurium besylate 0.15 mg/kg iv, when TOF count showed disappearance of T1 (0/4) endotracheal intubation with appropriate size will be accomplished and lungs will be mechanically ventilated to maintain the ETCO2 30-35 mmHg. - Anesthesia will be maintained with inspired isoflurane 1.5 % and cisatracurium besylate top up doses 0.03 mg/kg/30 min will be given guided with TOF count aiming to keep it as 1/4. Airway will be secured by oro-pharyngeal packing and patients will be positioned supine with head up 30°. Dexamethasone 0.2 mg/kg and metoclopramide 10 mg slowly iv will be given as emesis prophylaxis. - Deliberate hypotension will be induced until completion of the main surgical procedures to achieve a MAP within the target range of 55‒65 mm Hg (approximately 30% below a patient's usual MAP), nitroglycerin (1mg/ml) with a dose range 5-20 mcg/min will be added if needed. - All patients will be operated upon by the same surgical team. - Bleeding in the surgical field and the quality of the visibility will be assessed subjectively by the surgeon who will be blinded to the infused drug using 6 points scale adapted by Boezaart et al.(25): - 0= no bleeding. - 1= slight bleeding so blood evacuation not necessary. - 2= slight bleeding so sometimes blood has to be evacuated. - 3= low bleeding so blood has to be often evacuated and operative field is visible for some seconds after evacuation. - 4= average bleeding so blood has to be often evacuated, and operative field is visible only right after evacuation. - 5= high bleeding so constant blood evacuation is needed, sometimes bleeding exceeds evacuation and surgery is hardly possible. The 1st assessment will be 30 min after the beginning of surgery and then every 30 min till the end of surgery. - As an objective method, the volume of fluid aspirated from the surgical field during surgery will be also measured. - When blood loss exceed 300 mL, 6% hydroxyethyl starch solutions (Voluven, Fresinius Kabi, Bad Homberg, Germany) will be administered at a 1:1 ratio, and if hematocrit is <27%, a transfusion will be initiated . - Hypotension (MAP<55 mm Hg) will be treated with ephedrine 15 mg intravenous. - Bradycardia (HR˂ 50) will be recorded and managed with atropine 0.02mg/kg. - With termination of surgery, isoflurane will be discontinued, the oropharyngeal pack will be removed and the oropharynx will be suctioned under direct vision using the rigid laryngoscope. The residual cisatracurium will be reversed with neostigmine 0.05 mg/kg iv and atropine 0.02 mg/kg iv when the TOF count is 2/4, trachea will be extubated once the patients showed eye opening and purposeful movement and then patients will be transferred to PACU where BP, SpO2 and ECG will be monitored. O2 supplementation will be provided via face mask. Measurements: The following parameters will be measured and will be statistically analyzed between the two studied groups: 1. Demographic data (age and sex). 2. Hemodynamic variables: - Mean arterial blood pressure (MABP) in mmHg by invasive monitoring using GE monitor . - Heart rate: (beats / minute) using GE monitor. Time Points for Hemodynamic Parameter Measurements: - Baseline before induction of anesthesia. - Before starting the infusion of NTG (baseline) - 5 minutes after initiation of NTG - Every 30 min throughout deliberate hypotension till termination of NTG infusion. - 5 minutes after the end of deliberate hypotension - Immediately after extubation in the operating room - 60 min after extubation in the PACU 3. The amount of nitroglycerin used: - Duration of DH (min( - NTG amounts during DH (μg/kg/min). 4. Blood loss and need for blood transfusion: - Intraoperative bleeding (mL). - Intraoperative autologous blood transfusion (units of packed RBCs). 5. Total urine output (mL). 6. Laboratory investigations: - Random blood sugar (RBS) - Serum lactate level. Both will be measured immediately after induction of anesthesia, and after discontinuation of deliberate hypotension (NTG infusion). 7. Duration of surgery (the time from start of surgical intervention till its end) (min.). 8. Patients administered ephedrine during DH (n). 9. Events of bradycardia (frequency). 10. Complications need intervention such as bronchospasm, laryngospasm, or vomiting will be recorded and managed.

    Phase

    N/A

    Span

    25 weeks

    Sponsor

    Alexandria University

    Recruiting

  • Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

    Phase

    4

    Span

    19 weeks

    Sponsor

    Cairo University

    Recruiting

  • Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

    Phase

    3

    Span

    73 weeks

    Sponsor

    Brugmann University Hospital

    Recruiting

  • a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

    Phase

    3

    Span

    115 weeks

    Sponsor

    King Faisal Specialist Hospital & Research Center

    Recruiting

1-10 of 29
CenterWatch

5000 Centregreen Way, Suite 200
Cary, NC, 27513, USA

Phone: 609.945.0101

  • Disclaimer
  • Privacy Policy
  • Term of Use
  • Do Not Sell My Personal Information