drugset / Trial / NCT00527332
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
RandomizedParallel-groupOpen-labelSupportive care
Summary
The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-06
- Completion
- 2009-12
Publications
- Background Vårdtid, funktionskapacitet och sjukskrivningstider efter hysterektomi. Nationella data från 6503 patienter opererade år 2000 och 2001. Återrapport från Nationella registret för kvalitetsutveckling inom gynekologisk kirurgi (Gynop-registret), SFOG, 2003.
- Background Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
- Background Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.
- Background Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6.
- Background Persson P, Wijma K, Hammar M, Kjolhede P. Psychological wellbeing after laparoscopic and abdominal hysterectomy--a randomised controlled multicentre study. BJOG. 2006 Sep;113(9):1023-30. doi: 10.1111/j.1471-0528.2006.01025.x.
- Background Ellstrom MA, Astrom M, Moller A, Olsson JH, Hahlin M. A randomized trial comparing changes in psychological well-being and sexuality after laparoscopic and abdominal hysterectomy. Acta Obstet Gynecol Scand. 2003 Sep;82(9):871-5. doi: 10.1080/j.1600-0412.2003.00216.x.
- Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
- Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 20 mg | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | 50 ug | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 100 ug | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 200 ug | Intravenous |
| Comparator | Morphine | Other / unclassified | 0.2 mg | Intrathecal |
| Comparator | Morphine | Other / unclassified | 5 mg | Intrathecal |
| Comparator | Propofol | Small molecule | 1 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 2 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 5 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 6 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 10 mg/kg | Intravenous |
| Comparator | Rocuronium | Other / unclassified | 0.6 mg/kg | Intravenous |
| Comparator | Rocuronium | Other / unclassified | 5 mg | Intravenous |
| Comparator | Rocuronium | Other / unclassified | 10 mg | Intravenous |
Indications
No indication recorded.