Caesarean Section Clinical Trial
Official title:
Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Mother scheduled for elective caesarean delivery at the Princess Royal Maternity Unit, Glasgow. Exclusion Criteria: - Patient refusal - Severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. Barrett's Oesophagus.) - Diabetes mellitus requiring treatment beyond dietary modulation - Unable to consent - Patients undergoing general anaesthetic should be excluded from the study. - Anticipated complex caesarean section patients. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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NHS Greater Glasgow and Clyde | Obstetric Anaesthetists' Association |
Agarwal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989 Aug;44(8):632-4. — View Citation
Clark, A & Agaram, R. (2014) Too fast? Ketonuria as a marker of prolonged fasting in elective caesarean section. International Journal of Obstetric Anaesthesia 23, Supplement 1, S1-S62.
Clark, A., Soosay, A., Litchfield, K., Agaram, R. (2015) Carbohydrate Loading for Elective Caesarean Delivery. International Journal of Obstetric Anesthesia. 24, Sup
Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17. — View Citation
Gustafsson UO, Nygren J, Thorell A, Soop M, Hellström PM, Ljungqvist O, Hagström-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7. — View Citation
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(®)) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. — View Citation
Lucas DN, Gough KL. Enhanced recovery in obstetrics--a new frontier? Int J Obstet Anesth. 2013 Apr;22(2):92-5. doi: 10.1016/j.ijoa.2013.02.001. Epub 2013 Mar 9. — View Citation
Metzger BE, Ravnikar V, Vileisis RA, Freinkel N. "Accelerated starvation" and the skipped breakfast in late normal pregnancy. Lancet. 1982 Mar 13;1(8272):588-92. — View Citation
Neufer PD, Costill DL, Flynn MG, Kirwan JP, Mitchell JB, Houmard J. Improvements in exercise performance: effects of carbohydrate feedings and diet. J Appl Physiol (1985). 1987 Mar;62(3):983-8. — View Citation
Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylén L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. — View Citation
Obstetric Anaesthetists' Association (2012). GENERAL ANAESTHETIC FOR UNPLANNED CAESAREAN SECTION (CS) INFORMATON CARD. http://www.labourpains.com/assets/_managed/editor/File/Info%20for%20Mothers/GA%20for%20unplanned%20CS/GA_Unplanned_CS.pdf.pdf accessed 23/04/15.
Scott MJ, Fawcett WJ. Oral carbohydrate preload drink for major surgery - the first steps from famine to feast. Anaesthesia. 2014 Dec;69(12):1308-13. doi: 10.1111/anae.12921. Epub 2014 Oct 23. — View Citation
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review. — View Citation
Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. — View Citation
Wong CA, McCarthy RJ, Fitzgerald PC, Raikoff K, Avram MJ. Gastric emptying of water in obese pregnant women at term. Anesth Analg. 2007 Sep;105(3):751-5. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of aspiration of gastric contents under general anaesthesia | Inhalation of gastric contents | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to two weeks duration | |
Primary | Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery. | After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer) | From insertion of urinary catheter until 5 minutes post urinary catherisation | |
Secondary | Preoperative thirst | Assessed via visual analogue scale | On arrival to theatre - 5 minutes duration for questioning | |
Secondary | Preoperative hand grip strength | Dominant hand grip strength measures with dynamometer | On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration | |
Secondary | Length of hospital stay | Measured length of stay between hospital admission and discharge home | From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration |
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