Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study

Caesarean Section Clinical Trial

Official title:

Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03220997
• Other study ID #: GN16OG711
• Status: Not yet recruiting
• Phase: N/A
• First received: June 6, 2017
• Last updated: July 17, 2017
• Start date: August 2017
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: Andrew Clark
• Phone: 07841525587
• Email: andrewclark85[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. This is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents).

However, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. Fasting increases anxiety levels and leads to poor patient satisfaction with the care received.

Recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation.

Carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed Enhanced recovery after surgery (ERAS). The benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. However, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. We hope to address this gap in the knowledge with our proposed study.

All mothers undergoing a planned caesarean section in the Princess Royal Maternity (PRM) will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. Information collected from the groups will be compared to evaluate the expected benefits and risks. The study will continue until the target sample size of 100 mothers in each of the two study groups is reached.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Caesarean Section
• Starvation

Intervention

Dietary Supplement:
• Vitaflow Preload
Carbohydrate loading drink

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Obstetric Anaesthetists' Association

References & Publications (15)

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

Outcome

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