BMC Veterinary Research | |
Multicenter clinical evaluation of a multi-dose formulation of propofol in the dog | |
Elizabeth M Cozzi1  Robbin L Koenig4  Sheilah A Robertson2  Ralph C Harvey3  James S Gaynor5  Khursheed R Mama6  | |
[1] Abbott Laboratories, Abbott Park, Illinois 60064, USA;Department of Large Animal Clinical Sciences, College of Veterinary Medicine, University of Florida, Gainesville, FL 32608, USA;Department of Small Animal Clinical Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, TN 37996, USA;Biotechnical Services, Inc, North Little Rock, AR 72116, USA;Peak Performance Veterinary Group, Colorado Springs, Co 80918, USA;Department of Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA | |
关键词: Propofol; Clinical trial; Anesthesia; Dog; | |
Others : 1119377 DOI : 10.1186/1746-6148-9-261 |
|
received in 2013-05-06, accepted in 2013-12-16, 发布年份 2013 | |
【 摘 要 】
Background
Propofol is a widely used injectable anesthetic agent for induction and short-term maintenance in dogs. A multi-dose formulation of propofol (MDP) has been developed which includes 2% benzyl alcohol as a preservative. In order to document the use of the product under clinical conditions, MDP was tested in a prospective clinical trial conducted at six sites within the United States. One hundred thirty-eight healthy, client-owned dogs were assigned to one of six treatment groups based on premedicants (none, acepromazine/buprenorphine, midazolam/buprenorphine, medetomidine/buprenorphine) and maintenance agents (MDP, inhaled anesthetic). Anesthesia was induced by the intravenous administration of MDP given to effect. Physiological indices including heart rate, respiratory rate and blood pressure were monitored prior to and during anesthesia induction, maintenance and recovery. Adverse events, defined for severity by pre-established limits of these physiological values, as well as side effects, defined as any observation outside the normal range, were noted.
Results
The mean intubation dose was 7.6 ± 2.1 mg/kg for MDP alone and 4.7 ± 1.3, 4.0 ± 1.0 mg/kg and 3.2 ± 1.4 mg/kg when buprenorphine was used in combination with midazolam, acepromazine and medetomidine, respectively. Of the 32 adverse events, apnea (12 incidents), bradycardia (9 incidents) and hypotension (7 incidents) were most frequently recorded. Emesis, cyanosis and second degree heart block were each noted once and successfully resolved. The cause of a single death 2 days post-anesthesia was assessed as a surgical complication.
Conclusions
MDP was found to be acceptable for use in healthy dogs for induction and short term maintenance of anesthesia when used alone and in combination with premedicants and inhaled anesthetics.
【 授权许可】
2013 Mama et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150208062653708.pdf | 228KB | download |
【 参考文献 】
- [1]Freedom of information act summary, new animal drug application for RapinovetTM(propofol) anesthetic injection for dogs and cats, NADA 141–070, 1996. http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm116781.pdf webcite
- [2]Short CE, Bufalari A: Propofol anesthesia. Vet Clin North Am Small Anim Pract 1999, 29:747-778.
- [3]Freedom of information act summary, new animal drug application for PropoFloTM, NADA 141–098, 1998. http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm355533.pdf webcite
- [4]Brunson EL: Benzyl alcohol. In Handbook of pharmaceutical excipients. 5th edition. Edited by Rowe RC, Sheskey PJ, Owen SC. London: Pharmaceutical Press; 2005:53-55.
- [5]Freedom of information act summary, supplemental new animal drug application for Propofol 28, NADA 141–098, 2011. http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm248263.pdf webcite
- [6]Branson KR, Quandt JE, Martinez EA, Carroll GL, Trim CM, Dodam JR, Hartsfield SM, Matthews NS, Mackenthun A, Beleau MH: A multisite case report on the clinical use of sevoflurane in dogs. J Am Anim Hosp Assoc 2001, 37:420-432.
- [7]Gershanik J, Boeder B, Ensley H, McCloskey S, George W: The gasping syndrome and benzyl alcohol poisoning. N Engl J Med 1982, 307:1384-1388.
- [8]Schleifer JH, Carson TL: Toxicity of benzyl alcohol preservative. J Am Vet Med Assoc 1982, 181:853.
- [9]Murrell JC, van Notten RW, Hellebrekers LJ: Clinical investigation of remifentanil and propofol for the total intravenous anaesthesia of dogs. Vet Rec 2005, 156:804-808.
- [10]Ludbrook GL, Upton RN, Grant C, Martinez A: The effect of rate of administration on brain concentrations of propofol in sheep. Anesth Analg 1998, 86:1301-1306.
- [11]Stokes DN, Hutton P: Rate-dependent induction phenomena with propofol: implications for the relative potency of intravenous anesthetics. Anesth Analg 1991, 72:578-583.
- [12]Geel JK: The effect of premedication on the induction dose of propofol in dogs and cats. J S Afr Vet Assoc 1991, 62:118-123.
- [13]Morgan DWT, Legge K: Clinical evaluation of propofol as an intravenous anaesthetic agent in cats and dogs. Vet Rec 1989, 124:31-33.
- [14]Watkins SB, Hall LW, Clarke KW: Propofol as an intravenous anaesthetic agent in dogs. Vet Rec 1987, 120:326-329.
- [15]Hall LW, Chambers JP: A clinical trial of propofol infusion anaesthesia in dogs. J Small Anim Pract 1987, 28:623-637.
- [16]Weaver BMQ, Raptopoulos D: Induction of anaesthesia in dogs and cats with propofol. Vet Rec 1990, 126:617-620.
- [17]Watney GCG, Pablo LS: Median effective dosage of propofol for induction of anesthesia in dogs. Am J Vet Res 1992, 53:2320-2322.
- [18]Grint NJ, Alderson B, Dugdale AHA: A comparison of acepromazine-buprenorphine and medetomidine-buprenorphine for preanesthetic medication of dogs. J Am Vet Med Assoc 2010, 237:1431-1437.
- [19]Sano T, Nishimura R, Mochizuki M, Sasaki N: Effects of midazolam-butorphanol, acepromazine-butorphanol and medetomidine on an induction dose of propofol and their compatibility in dogs. J Vet Med Sci 2003, 65:1141-1143.
- [20]Kuusela E, Vainio O, Short CE, Leppaluoto J, Huttunen P, Strom S, Hujo V, Valtonen A, Raekallio M: A comparison of propofol infusion and propofol/isofluorane anaesthesia in dexmedetomidine premedicated dogs. J Vet Pharmacol Ther 2003, 26:199-204.
- [21]Kuusela E, Raekallio M, Vaisanen M, Mykkanen K, Ropponen H, Vainio O: Comparison of medetomidine and dexmedetomidine as premedicants in dogs undergoing propofol-isoflurane anesthesia. Am J Vet Res 2001, 62:1073-1079.
- [22]Smith JA, Gaynor JS, Bednarski RM, Muir WW: Adverse effects of administration of propofol with various preanesthetic regimens in dogs. J Am Vet Med Assoc 1993, 202:1111-1115.
- [23]Musk GC, Pang DSJ, Beths T, Flaherty DA: Target-controlled infusion of propofol in dogs – evaluation of four targets for induction of anesthesia. Vet Rec 2005, 157:766-770.
- [24]Hammond RA, England GCW: The effect of medetomidine premedication upon propofol induction and infusion anaesthesia in the dog. J Vet Anaesth 1994, 21:24-28.
- [25]Goodchild CS, Serrao JM: Cardiovascular effects of propofol in the anaesthetized dog. Br J Anaesth 1989, 63:87-92.
- [26]Pypendop BH, Verstegen JP: Hemodynamic effects of medetomidine in the dog: a dose titration study. Vet Surg 1998, 27:612-622.
- [27]Murrell JC, Hellebrekers LJ: Medetomidine and dexmedetomidine: a review of cardiovascular effects and antinociceptive properties in the dog. Vet Anaesth Analg 2005, 32:117-127.
- [28]Muir WW, Gadowski JE: Respiratory depression and apnea induced by propofol in dogs. Am J Vet Res 1998, 59:157-161.
- [29]Alibhai HIK, Clarke KW, Lee YH, Thompson J: Cardiopulmonary effects of combinations of medetomidine hydrochloride and atropine sulphate in dogs. Vet Rec 1996, 138:11-13.
- [30]Kojima K, Nishimura R, Mutoh T, Takao K, Matsunaga S, Mochizuki M, Sasaki N: Comparison of sedative effects of medetomidine-midazolam, acepromazine-butorphanol and midazolam-butorphanol in dogs. J Am Vet Med Assoc 1999, 46:141-148.
- [31]Pypendop B, Verstegen J: A comparison of the sedative and analgesic effects of buprenorphine in combination with acepromazine, midazolam or medetomidine in dogs. J Vet Anaesth 1994, 21:15-20.
- [32]Kimura ET, Darby TD, Krause RA, Brondyk HD: Parenteral toxicity studies with benzyl alcohol. Toxicol Appl Pharmacol 1971, 18:60-68.
- [33]Cullison RF, Menard PD, Buck WB: Toxicosis in cats from use of benzyl alcohol in lactated Ringer’s solution. J Am Vet Med Assoc 1983, 182:61.
- [34]McCloskey SE, Gershanik JJ, Letora JJ, White L, George WJ: Toxicity of benzyl alcohol in adult and neonatal mice. J Pharm Sci 1986, 75:702-705.
- [35]European Commission Health and Consumer Protection Directorate-General: Opinion of the scientific committee on food on benzyl alcohol. Brussels: European Commission; 2002. SCF/ADD/FLAV/78 Final 17 Sept
- [36]Wilcke JR: Idiosyncracies of drug metabolism in cats: effects on pharmacotherapeutics in feline practice. Vet Clin North Am Small Anim Pract 1984, 14:1345-1354.
- [37]Taylor PM, Chengelis CP, Miller WR, Parker GA, Gleason TR, Cozzi E: Evaluation of propofol containing 2% benzyl alcohol preservative in cats. J Feline Med Surg 2012, 14:516-526.
- [38]Abbott Laboratories: In use stability study for multi-dose propofol. Abbott Park, IL: Abbott Laboratories; 2010.