Caesarean Section, Starvation
Conditions
Keywords
Sequela, Ketosis
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTVitaflow Preload
Carbohydrate loading drink
Sponsors
Obstetric Anaesthetists' Association United Kingdom
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Research midwives will attend consent, randomise, collect baseline data and provide the accompanying information and carbohydrate sachets to subjects. The research fellows will be blinded but will collect the data for participants. The research midwives will complete study compliance. To achieve this, participants will bring to ward a completed compliance form ( given at randomisation) in a sealed envelope this will ensure the research investigators remain blinded during their pre op assessments and data collection.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery. | From insertion of urinary catheter until 5 minutes post urinary catherisation | After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative thirst | On arrival to theatre - 5 minutes duration for questioning | Assessed via visual analogue scale |
| Preoperative hand grip strength | On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration | Dominant hand grip strength measures with dynamometer |
| Length of hospital stay | 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 | Measured length of stay between hospital admission and discharge home |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of aspiration of gastric contents under general anaesthesia | 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 | Inhalation of gastric contents |
Contacts
Primary ContactAndrew Clark
Backup ContactKerry Litchfield
Outcome results
None listed