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Tiletamine/zolazepam and dexmedetomidine with tramadol provide effective general anesthesia in rats

Animal Models and Experimental Medicine 2021年第1期4卷 40-46页

作者： Vudhiporn Limprasutr Patrick Sharp Katechan Jampachaisri Cholawat Pacharinsak Sumit Durongphongtorn Department of Pharmacology and Physiology Faculty of Pharmaceutical SciencesChulalongkorn UniversityBangkokThailand Research Clusters:Preclinical Toxicity and Efficacy Assessment of Medicines and Chemicals Chulalongkorn UniversityBangkokThailand Animal Resources Centre MurdochWAAustralia Department of Mathematics Faculty of SciencesNaresuan UniversityPhitsanulokThailand Department of Comparative Medicine School of MedicineStanford UniversityStanfordCAUSA Department of Veterinary Surgery Faculty of Veterinary ScienceChulalongkorn UniversityBangkokThailand

Background:Tiletamine/zolazepam is a dissociative anesthetic combination commonly used in small animals but information is limited in rats.The alpha-2 agonist,dexmedetomidine,has gained popularity in laboratory animal anesthesia.tramadol is a weak opioid mu agonist.The aim of this study was to assess whether the tiletamine/zolazepam/dexmedetomidine(ZD)combination effectively provides a surgical anesthesia plane comparable to tiletamine/zolazepam/dexmedetomidine with tramadol(ZDT)in a minor procedure in rats.Methods:Rats were induced with ZD or ZDT.After the loss of paw withdrawal,a small incision was made on the rats’left thighs as a surgical stimulus.Rats were maintained under a surgical anesthesia plane by assessing the loss of the paw withdrawal reflex for 45 minutes,then atipamezole was administered.Monitored anesthesia parameters included:(a)physiological parameters-pulse rate(PR),respiratory rate(RR),tissue oxygen saturation(%SpO 2),and body temperature;(b)duration parameters-induction time,onset and duration of surgical anesthesia plane,onset of recovery,and recovery time.Results:PR was significantly lower at 10 minutes in ZD and 5 minutes in ZDT groups.No difference was observed for RR,%SpO 2,and body temperature.Likewise,there were no differences for duration parameters:induction time was less than 3 minutes;onset and duration of surgical anesthesia plane were approximately 5 and 45 minutes,respectively;onset of recovery(time to move)was 51 minutes;and recovery time was 52 minutes,respectively.Conclusion:These data suggest the ZD combination provides a surgical anesthesia plane comparable to ZDT in a rat incisional pain model.

关键词： anesthesia dexmedetomidine rats tiletamine tramadol

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Enhancement in antinociceptive and anti-inflammatory effects of tramadol by transdermal proniosome gel

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Asian Journal of Pharmaceutical Sciences 2020年第6期15卷 786-796页

作者： Jigar Shah Anroop B.Nair Hiral Shah Shery Jacob Tamer M.Shehata Mohamed Aly Morsy Institute of Pharmacy Nirma UniversityAhmedabad 382481India College of Clinical Pharmacy King Faisal UniversityAl-Ahsa 31982Saudi Arabia Arihant School of Pharmacy&BRI Gandhinagar 382421India College of Pharmacy Gulf Medical UniversityAjman 4184United Arab Emirates Faculty of Pharmacy University of ZagazigZagazig 44519Egypt Faculty of Medicine Minia UniversityEl-Minia 61511Egypt

Oral therapy of tramadol,an opiate analgesic,undergoes extensive hepatic metabolism and requires frequent administration.Transdermal therapy by virtue can overcome these issues and can improve the efficacy and reduce abuse liability of tramadol.The aim of this research was to investigate the possibility of transdermal delivery of tramadol by formulating proniosome gel and evaluate its therapeutic potential in vivo.The effect of formulation composition as well as amount of drug on physicochemical characteristics of prepared proniosomes were examined.Best proniosome gel(F4)was selected and evaluated for drug release,stability and transdermal efficacy by ex vivo and in vivo experiments.The vesicles demonstrated optimal properties including spherical shape,nanosize with good entrapment efficiency,adequate zeta potential,higher stability and greater transdermal flux.The amorphization and dispersion of tramadol in the aqueous core of proniosome vesicles was confirmed by differential scanning calorimeter.Release profile of F4 was distinct(Ptramadol release by Fickian diffusion.Transdermal therapy of F4 showed prominent reduction of induced twitches(Ptramadol.The improvement in clinical efficacy of tramadol in transdermal therapy is correlated with the pharmacokinetic data observed.In conclusion,the observed improvement in antinociceptive and anti-inflammatory effects from proniosome carriers signifies its potential to be a suitable alternative to oral therapy of tramadol with greater efficacy.

关键词： tramadol Proniosomes Flux Edema Pharmacokinetics Rats

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Therapeutic levels of short-term tramadol administration negatively affect testis function in rats

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Asian pacific Journal of Reproduction 2021年第1期10卷 29-35页

作者： Jonah Sydney Aprioku Benjamin Toochukwu Okpe Doupere Ben Department of Experimental Pharmacology and Toxicology Faculty of Pharmaceutical SciencesUniversity of Port HarcourtPMB 5323East-West RoadRivers StateNigeria Department of Pharmacology and Toxicology Faculty of PharmacyNiger Delta UniversityWilberforce IslandBayelsa StateNigeria

Objective:To investigate the effects of 30-day treatment with therapeutic dose equivalent levels of tramadol on serum testosterone level,sperm parameters,and testicular histology in rats.Methods:Thirty-five Wistar rats were equally divided into seven groups.Group 1(the control group)received distilled water(0.5 mL)daily for 30 days.Groups 2-4 were gavaged with therapeutic dose equivalent levels of tramadol(1.25,2.50 and 5.00 mg/kg/day body weight,respectively)in two equal divided doses for 30 consecutive days,and sacrificed on day 31.Groups 5-7 received similar tramadol treatments as above but they were allowed for another 30 days to recover after receiving the last dose and sacrificed on day 61 for reversibility study.Serum testosterone level and epididymal sperm were analyzed,and histopathological examination of the testis was carried out.Results:tramadol treatment significantly decreased serum testosterone levels compared with the control group.Furthermore,tramadol treatment inhibited sperm motility and significantly and dose-dependently decreased sperm count and viability compared with the control group.In addition,tramadol significantly increased morphological abnormalities in sperm(Ptramadol were reduced in the reversible groups.Testis histopathological examination revealed disintegrated cell architecture,eroded and atrophied seminiferous tubules,and a marked decrease in the number of spermatogenic cells in the tramadol treated groups.The histopathological changes were restored in the reversible groups,but improvement was not complete in the 5.00 mg/kg tramadol treated reversible group.Conclusions:Long term treatment with tramadol at clinical dose levels may adversely affect testosterone level,sperm parameters,and testicular histology,but they are reversible at lower doses.

关键词： tramadol Testosterone Sperm parameters Opioid analgesic Testicular function

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Acetylcholinesterase,butyrylcholinesterase and paraoxonase 1 activities in rats treated with cannabis,tramadol or both

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Asian Pacific Journal of Tropical Medicine 2016年第11期9卷 1066-1071页

作者： Omar M.E.Abdel-Salam Eman R.Youness Yasser A.Khadrawy Amany A.Sleem Department of Toxicology and Narcotics National Research Centre Cairo Department of Medical Biochemistry National Research Centre Cairo Department of Physiology National Research Centre Cairo Department of Pharmacology National Research Centre Cairo

Objective:To investigate the effect of Cannabis sativa resin and/or tramadol,two commonly drugs of abuse on acetylcholinesterase and butyrylcholinesterase activities as a possible cholinergic biomarkers of neurotoxicity induced by these agents.Methods:rats were treated with cannabis resin(5,10 or 20 mg/kg)(equivalent to the active constituent A'-tetrahydrocannabinol),tramadol(5,10 and 20 mg/kg) or tramadol(10 mg/kg)combined with cannabis resin(5,10 and 20 mg/kg) subcutaneously daily for 6 weeks.Acetylcholinesterase(AChE) and butyrylcholinesterase(BChE) activities were measured in brain and serum.We also measured the activity of paraoxonase-1(PONl) in serum of rats treated with these agents.Results:(i) AChE activity in brain increased after 10-20 mg/kg cannabis resin(by 16.3%-36.5%).AChE activity in brain did not change after treatment with 5-20 mg/kg tramadol.The administration of both cannabis resin(5,10 or 20 mg/kg) and tramadol(10 mg/kg) resulted in decreased brain AChE activity by 14.1%,12.9%and 13.6%,respectively;(ii) BChE activity in serum was markedly and dose-dependenlly inhibited by cannabis resin(by 60.9%-76.9%).BChE activity also decreased by 17.6%-36.5%by 10-20mg/kg tramadol and by 57.2%-63.9%by the cannabis resin/tramadol combined treatment;(iii)Cannabis resin at dose of 20 mg/kg increased serum PONl activity by 25.7%.In contrast,tramadol given at 5,10 and 20 mg/kg resulted in a dose-dependent decrease in serum PON1 activity by 19%,36.7%,and 46.1%,respectively.Meanwhile,treatment with cannabis resin plus tramadol resulted in 40.2%,35.8%,30.7%inhibition of PONl activity compared to the saline group.Conclusions:these data suggest that cannabis resin exerts different effects on AChE and BChE activities which could contribute to the memory problems and the decline in cognitive function in chronic users.

关键词： Cannabis sativa tramadol Cholinesterases Memory Cognitive decline

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Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation

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Asian Journal of Andrology 2013年第1期15卷 138-142页

作者： Bayoumy I Eassa Mohamed A EI-Shazly Department of DermatoLogy Venereology and Andrology AI-Azhar University Cairo 11884 Egypt Department of Urology Menoufiya University Cairo 32511 Egypt

Premature ejaculation （PE） is the most common sexual disorder. It affects 20%-30% of adult men; the aetiology of this condition has not yet been elucidated. The aim of this study is to evaluate the efficacy, safety, tolerability, undesirable effects and improved satisfaction with sexual intercourse with tramadol hydrochloride at different dosages for the treatment of PE. A total of 300 patients who presented with lifelong （primary） PE were included in this study. The study was performed for 28 weeks, in which placebo （starch tablet） was given for 4 weeks, and active ingredient （tramadol hydrochloride） was administered at different therapeutic dosages for 24 weeks. Patients were divided into three equal groups, each consisting of 100 patients. The first group （A） was given tramadol hydrochloride capsule 25 mg. The second group （B） was given tramadol hydrochloride capsule 50 mg. The third group （C） was given tramadol hydrochloride capsule 100 mg. All of the 300 participants included completed the study voluntarily. The age of the patients varied from 25 to 50 years. After the treatment period, the recorded data were collected for each group and analysed. The results showed a highly significant increase in the mean intravaginal ejaculatory latency time （IELT） in all groups compared to baseline data （P〈0.0001）. We concluded that using tramadol hydrochloride at different doses on demand for the treatment of PE is effective, safe and tolerable, with minimal undesirable effects, and approval for this indication should be souRht.

关键词： early ejaculation erectile dysfunction intravaginal ejaculation latencytime premature climax premature ejaculation PE rapid ejaculation tramadol

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Comparative effect of intrathecal meperidine,tramadol,magnesium sulfate,and dexmedetomidine on preventing post-spinal anesthesia shivering and adverse events in hip fracture repair patients:A randomized clinical trial

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Journal of Acute Disease 2022年第6期11卷 222-227页

作者： Mansoreh Kokhaei Hesameddin Modir Esmail Moshiri Mehran Azami Students Research Committee Arak University of Medical SciencesArakIran Departments of Anesthesiology and Critical Care Arak University of Medical SciencesArakIran Departments of Orthopedic Surgery Arak University of Medical SciencesArakIran

Objective:To compare effect of intrathecal meperidine,tramadol,magnesium sulfate,and dexmedetomidine on the prevention of post-spinal anesthesia shivering and adverse events in hip fracture repair patients.Methods:In a randomized,double-blind trial,132 patients with American Society of Anesthesiology(ASA)ⅠandⅡspinal anesthesia who needed hip fracture surgery were enrolled.Patients were stratified into 4 intervention groups based on a randomized block pattern:meperidine,tramadol,magnesium sulfate,and dexmedetomidine.Hemodynamic parameters including blood pressure,heart rate,and oxygen saturation,as well as the severity of shivering,core body temperature,Ramsay sedation score,adverse events,meperidine consumption were recorded and compared.Results:There was no statistically significant difference in the normal hemodynamic parameters,temperature,duration of surgery,meperidine consumption,and adverse events such as dizziness,hypotension,nausea,and bradycardia among groups(P>0.05).Compared to other groups,severity of shivering was the lower in the dexmedetomidine group 6 and 8 h after surgery.The Ramsay sedation scores were higher in the dexmedetomidine and meperidine groups 4 h after surgery(P=0.020).Conclusion:Dexmedetomidine acts better than the other three adjuvants in reducing complications such as shivering.Overall,these four adjuvants are helpful to prevent postoperative shivering and could be put forward as promising local anesthetics in spinal anesthesia,based on anesthesiologists’discretion and patients’general conditions.Clinical registration:The study was approved by the Research and Ethics Committee at the Valiasr Hospital(Arak,Iran)with the clinical trial code of IRCT20141209020258N153.

关键词： Dexmedetomidine Hip fracture Intrathecal injec-tion Magnesium sulfate Meperidine Shivering Spinal tramadol

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Estimation of the minimum effective dose of tramadol for postoperative analgesia in infants using the continual reassessment method

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Frontiers of Medicine 2012年第3期6卷 288-295页

作者： Yue’e Dai Dongxu Lei Zhenghua Huang Yan Yin GAllen Finley Yunxia Zuo Department of Anesthesiology and Translational Neuroscience Center West China HospitalSichuan UniversityChengdu 610041China Department of Anesthesiology Sichuan Academy of Medical Sciences&Sichuan Provincial People’s HospitalChengdu 610041China Department of Anesthesia and Psychology IWK Health CentreDalhousie University5850 University AvenueHalifaxNSB3K 6R8Canada

tramadol is a potent analgesic.However,the analgesia efficacy of tramadol,particularly its minimum effective dose(MED),is not clear.The aim of this study is to find MED of tramadol for postoperative analgesia in infants.The continual reassessment method(CRM)was performed to find MED.Infants undergoing surgeries were included in the 3 phases of this series.In each phase,24 participants were allocated a different tramadol dose.Pain intensity was measured by face,legs,activity,cry,consolability(FLACC)measurement at 3-hour intervals.tramadol was considered ineffective if the FLACC score was higher than 4 in 10 at anytime.In phase 1,seven dose levels were used within the range 0.1-0.4 mg·kg^(-1)·h^(-1).Phase 1 was insufficient to identify the MED,and we increased the dose to 0.4-0.8 mg·kg^(-1)·h^(-1) in phase 2.Phase 2 was insufficient to identify the MED.In phase 3,local anesthetic wound infiltration was introduced,and the tramadol dose levels tested were the same as in phase 1.The successful analgesia probability of tramadol 0.4 mg·kg^(-1)·h^(-1) was 82.1%(95%CI,0.742-0.925)in phase 1.In phase 2,it was 84.7%(95%CI,0.789-0.991)with the dose 0.8 mg·kg^(-1)·h^(-1).Phase 1 and phase 2 were insufficient to identify the MED.In phase 3,the successful analgesia probability for dose 0.35 mg·kg^(-1)·h^(-1) was 96.7%(95%CI,0.853-0.997).We have demonstrated that tramadol provides insufficient analgesia for surgeries considered to cause moderate-to-severe postoperative pain in infants if used as the sole analgesic,and that local anesthetic wound infiltration enhances the efficacy of tramadol.

关键词： tramadol minimum effective dose postoperative analgesia infants continual reassessment method

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A small-dose naloxone infusion alleviates nausea and sedation without impacting analgesia via intravenous tramadol

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Chinese Medical Journal 2010年第13期123卷 1695-1698页

作者： JIA Dong-lin NI Cheng XU Ting ZHANG Li-ping GUO Xiang-yang Department of Anesthesiology Peking University Third Hospital Beijing 100191 China

Background Early studies showed that naloxone infusion decreases the incidence of morphine-related side effects from intravenous patient-controlled analgesia. This study aimed to determine whether naloxone preserved analgesia while minimizing side effects caused by intravenous tramadol administration. Methods Eighty patients undergoing general anesthesia for cervical vertebrae surgery were randomly divided into four groups. All patients received 1 mg/kg tramadol 30 minutes before the end of surgery, followed by a continuous infusion with 0.3 mg-kg1.h^-1 tramadol with no naloxone （group I, n=20）, 0.05 μg.kg.^-1.h^-1 naloxone （group Ⅱ, n=20）, 0.1 pg.kg^-1.h^-1 naloxone （group Ⅲ, n=-20） and 0.2 μg.kg^-1.h^-1 naloxone （group Ⅳ, n=20）. Visual analog scales （VAS） for pain during rest and cough, nausea five-point scale （NFPS） for nausea and vomiting, and ramsay sedation score （RSS） for sedation were assessed at 2, 6, 12, 24 and 48 hours postoperatively. Analgesia and side effects were evaluated by blinded observers. Results Seventy-eight patients were included in this study. The intravenous tramadol administration provided the satisfied analgesia. There was no significant difference in either resting or coughing VAS scores among naloxone groups and control group. Compared with control group, sedation was less in groups Ⅱ, Ⅲ, and Ⅳ at 6, 12, and 24 hours （P 〈0.05）; nausea was less in groups Ⅱ, Ⅲ and Ⅳ than group I at 2, 6, 12, 24 and 48 hours postoperatively （P 〈0.05）. The incidence of vomiting in the control group was 35% vs. 10% for the highest dose naloxone group （group Ⅳ）（P 〈0.01）. Conclusion A small-dose naloxone infusion could reduce tramadol induced side effects without reversing its analgesic effects.

关键词： tramadol naloxone analgesia nausea sedation

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Clinical Observation on the Effects of Different Doses of tramadol lnjection for Preemptive Analgesia in Gynaecological Laparoscopy

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Chinese Journal of Biomedical Engineering(English Edition) 2016年第2期25卷 47-52页

作者： YAO Qun YAO Li Anesthesiology Department Municipal HospitalShandong Province Zaozhuang Gynecological Department Municipal HospitalShandong Province Zaozhuang

Objective: To observe the analgesic effects of tramadol in general anaesthesia for laparoscopic surgery. Methods: To operate 80 laparoscopic surgeries under the circumstance of general anaesthesia. Randomly divide them into 4 groups,with 20 cases in each group and the intravenous injection should be finished before the operation. Group Ⅰ: 2 ml normal saline; Group Ⅱ: 1.5 ml/kg tramadol; Group Ⅲ: 2mg/kg tramadol; Group Ⅳ : 2.5 mg/kg tramadol. Use VAS and Ramsay sedation marking system to assess the degree of pain-feeling and sedation in these circumstances: after pulling out oxygen hose, before leaving the operation room and1, 2, 4, 8, 12, 24 h after the operation. Meanwhile, record such side effects as nausea,vomiting, dizziness, hypersomnia, restless, nightmares, itchy and sweating. Results:The VAS score was significantly lower within postoperative 8 h in Group Ⅱ, Ⅲ andⅣ than that in Group I, while no significant difference was found among GroupⅡ, Ⅲand Ⅳ at each time point. The postoperative Ramsay sedation score was 0-2 in each group. Incidence of postoperative nausea, vomiting, and sweating were more in GroupⅡ, Ⅲ and IV than that in Group I. Group Ⅳ and Group I have statistical differences, in which Ptramadol provides satisfactory preoperative analgesia in patients undergoing gynaecological laparoscopy, reducing the use of analgesics and the incidence of side effects.

关键词： gynaecological laparoscopy analgesia general anaesthesia tramadol

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Effect of Transcutaneous Electrical Acupoint Stimulation on Nausea and Vomiting Induced by Patient Controlled Intravenous Analgesia with tramadol

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Chinese Journal of Integrative Medicine 2008年第1期14卷 61-64页

作者：郑丽宏孙红王国年梁洁吴华星 Department of Analgesia the Tumor Hospital Affiliated to Harbin Medical UniversityHarbin(150081)

Objective： To observe the effect of transcutaneous electrical acupoint stimulation （TEAS） on nausea and vomiting （N＆V） induced by patient controlled intravenous analgesia （PCIA） with tramadol. Methods： Sixty patients who were ready to receive scheduled operation for tumor in the head-neck region and post-operation PCIA, aged 39-65 years, with the physique grades Ⅰ -Ⅱ of ASA, were randomized into two groups, A and B, 30 in each group. The pre-operation medication, induction of analgesia and continuous anesthesia used in the two groups were the same. TEAS on bilateral Hegu （LI4） and Neiguan （PC6） points was intermittently applied to the patients in group A starting from 30 min before analgesia induction to 24 h after operation, and the incidence and score of nausea and vomiting, antiemetic used, visual analogue scores （VAS）, and PCIA pressing times in 4 time segments （0-4, 4-8, 8-12 and 12-24 h after the operation was finished） were determined. The same management was applied to patients in Group B, with sham TEAS for control. Results： The incidence and degree of N＆V, as well as the number of patients who needed remedial antiemetic in Group A were less than those in Group B. The VAS score and PCIA pressing time were lower in Group A than those in Group B in the corresponding time segments respectively. Conclusion： TEAS could prevent N＆V induced by PCIA with tramadol.

关键词： transcutaneous electrical acupoint stimulation patient controlled intravenous analgesia tramadol nausea and vomiting

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