Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03220997
Other study ID # GN16OG711
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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 allClick 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
See also
  Status Clinical Trial Phase
Completed NCT04238741 - Audio-recording of Consent for Anaesthesia for Elective Caesarean Section N/A
Terminated NCT03638011 - A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine Phase 4
Completed NCT01718236 - Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section Phase 4
Completed NCT03199170 - Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section N/A
Completed NCT03309163 - Effect of Tramadol in Prevention of Postpartum Depression Phase 4
Completed NCT03711552 - Validation of an Obstetric QoR Score and to Establish Its MCID.
Not yet recruiting NCT05583214 - Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia Phase 4
Recruiting NCT06070844 - Yoga Nidra and Pain After Caesarean Section N/A
Recruiting NCT06070792 - Neurolinguistic Programming, Progressive Muscle Relaxation Exercises, and Breastfeeding N/A
Recruiting NCT06135961 - Intrapartum Non-invasive Electrophysiological Monitoring N/A
Terminated NCT04435496 - Study to Evaluate the Learning Curve to Anchor GYN-CS® Device N/A
Completed NCT00916812 - Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics
Completed NCT05520580 - Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL N/A
Recruiting NCT02755168 - External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section N/A
Completed NCT02285569 - The Pleth Variability Index and Hypotension at Caesarean Under Spinal. N/A
Completed NCT01210300 - Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section N/A
Completed NCT03653442 - Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension
Completed NCT03134677 - The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section Phase 4
Not yet recruiting NCT05446311 - Naldebain® Extended-release Injection After Cesarean Section in Pain Management
Completed NCT01278238 - Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia N/A