What is the effect on nausea and vomiting during and after surgery of allowing patients to drink water freely before having a Caesarean section, compared to not eating or drinking for 6+ hours?
| ISRCTN | ISRCTN63282932 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63282932 |
| Secondary identifying numbers | 54826 -S1 |
- Submission date
- 29/09/2020
- Registration date
- 01/10/2020
- Last edited
- 27/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
A Caesarean section is an operation to deliver a baby through a cut made in the tummy and womb.
Women going for Caesarean section require anesthesia of the lower body.
All patients planned for elective Caesarean section are traditionally not allowed to eat or drink (fast) from 12 midnight before the operation. This is because when the anesthetic is used, the body's reflexes are temporarily stopped. If the stomach has food and drink in it, there's a risk of vomiting.
Several studies have proven that allowing patients to drink water up to the surgery call time is most effective in reducing the rate of nausea and vomiting hence improving the recovery time after surgery. However, the traditional practice is to keep patients fasted for a minimum of 6 hours. This study should prove that allowing pregnant patients to consume clear fluids until surgery call time will reduce the rate of vomiting and improve satisfaction rate.
Who can participate?
Pregnant women, more than or equal to 18 years of age, who are planned for elective caesarean section, who are not in labour.
What does the study involve?
Participants will be randomly allocated to 2 groups:
1. Kept fasted from 12 midnight before the operation
2. Light food up to 2am and water up to surgery call time
Participants will be closely monitored before, during, and after their surgery.
What are the possible benefits and risks of participating?
There may or may not be any benefits to participants. Information obtained from this study will help improve standard practice for all women going for elective caesarean sections.
For those who are kept fasted from midnight, there is a risk of hunger and thirst. They will be assessed from time to time and if required they will be administered fluids. For those patients who are allowed to take water freely till surgery call time they may be a very small risk of vomiting, those patients will be monitored and treatment will be given accordingly.
Where is the study run from?
University Malaya (Malaysia)
When is the study starting and how long is it expected to run for?
October 2019 to May 2022
Who is funding the study?
University Malaya (Malaysia)
Who is the main contact?
Dr Sabeetha Segaran, sabeetha23@gmail.com
Contact information
Scientific
No 25 jalan 20 / 8
Paramount gardens
Petaling jaya
46300
Malaysia
 ORCID ID |
0000-0002-1365-4025 |
|---|---|
| Phone | +60 (0)163225967 |
| sabeetha23@gmail.com |
Study information
| Study design | Single-centre clinical interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Preoperative standard fasting as opposed to free access to oral water in elective Caesarean sections – a randomised trial |
| Study hypothesis | Patient allowed to drink clear fluids up to operating theater (OT) call time have a lower vomiting rate and better satisfaction rate. |
| Ethics approval(s) | Approved 28/9/2020, Medical Research Ethics Committee (Institute of Research Management & Services (IPPP), Level 7, Research Management & Innovation Complex, University of Malaya, 50603 Kuala Lumpur; +60 03-79493209; ummc@ummc.edu.my), ref: 2020623-8813 |
| Condition | Nausea and vomiting associated with regional anesthesia during elective Caesarean section |
| Intervention | Current intervention as of 29/12/2020: Patients who have agreed to participate in the study will be randomised into two groups: 1. Kept fasted from 12 midnight before the operation 2. Light food up to 2 am and clear fluid (water) up to OT call time Patients from both the groups would be given standard aspiration prophylaxis at OT call time as per anaesthetic protocol – Mist Sodium citrate, IV Metaclopromide and IV Ranitidine _____ Previous intervention: Patients who have agreed to participate in the study will be randomised into 2 groups: 1. Kept fasted from 12 midnight before the operation 2. Light food up to 6 hours, clear fluids up to OT call time (max 500 ml of water) Patients from both the groups would be given standard aspiration prophylaxis at OT call time as per anaesthetic protocol – Mist Sodium citrate, IV Metaclopromide and IV Ranitidine |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 29/12/2020: 1. Presence of vomiting (assessed as yes or no) defined as any vomiting from the time of entry to OT up to 6 h after surgery 2. Patient satisfaction with the feeding strategy assessed on the day of discharge using a verbal numerical rating scale (VNRS) from 0 to 10 _____ Previous primary outcome measures: 1. Vomiting intraoperative = yes or no (any vomiting from the time of entry to OT until 6 hours after the start of the surgery) 2. Patient satisfaction – VNRS score 0 to 10 - assessed at day 1 post-operation |
| Secondary outcome measures | Current secondary outcome measures as of 29/12/2020: 1. Vomiting (yes or no): 1.1. Preoperative: Any vomiting from midnight to entry to OT 1.2. Intra-operative: Any vomiting from the time of entry to OT to OT end time 1.3. Immediate post-op: Any vomiting from the 6 h post-op up to 24 h post-op 1.4. Post-op Day 1: Any vomiting from 24 h post-op up to time of discharge 2. Feeling thirsty measured using VNRS (0 to 10) upon arrival to OT 3. Feeling hungry measured using VNRS (0 to 10) upon arrival to OT 4. Feeling nauseous measured using VNRS (0 to 10) upon arrival to OT 5. Blood glucose measured using Reflo at OT call time 6. Ketonuria or glycosuria measured using urine dipstick upon arrival to OT 7. Requirement for IV hydration (yes or no – based on clincal judgement) in ward and in reception 8. Heaving /retching (sub-vomiting) (yes or no) during the post-spinal to intraoperative interval 9. Blood pressure (mmHg) during the post-spinal to intraoperative interval 10. Medication given to maintain blood pressure during the post- spinal to intraoperative interval 11. Nausea measured using VNRS (0 to 10) post-op in OT 12. Post operation time to: 12.1. First oral feed 12.2. First flatus 12.3. Sitting up 12.4. Ambulation 13. Resting pain score (day 1 before mobilisation) VNRS 0 to 10 14. Maternal fever to discharge (>38°C) 15. Maternal complications: 15.1. Indication for admission to maternal ICU 15.2. Aspiration pneumonitis 15.3. Mallory-Weiss tear 16. Neonatal parameters: 16.1. Apgar score at 1 and 5 min 16.2. Birth weight 16.3. Indication for admission to neonatal ICU prior to maternal discharge _____ Previous secondary outcome measures: 1. Vomiting (yes or no): 1.1. Preoperative: Any vomiting from the time of fast from midnight to entry to OT 1.2. Intra operative: Any vomiting from the time of entry to OT to OT end time 1.3. Immediate post op: Any vomiting from the end of OT time till 24 hours post-op 1.4. Post op Day 1: Any vomiting from 24 hours post-op until time of discharge 2. Feeling thirsty measured using VNRS (0 to 10) upon arrival to OT 3. Feeling hungry measured using VNRS (0 to 10) upon arrival to OT 4. Feeling nauseous measured using VNRS (0 to 10) upon arrival to OT 5. Blood glucose measured using Refloflux upon arrival to OT 6. Ketonuria or glycosuria measured using urine dipstick upon arrival to OT 7. Nausea measured using VNRS (0 to 10) post-op in OT 8. Requirement for IV hydration (yes or no – based on clincal judgement) in ward and in reception 9. Heaving /retching (sub-vomiting) (yes or no) during the post- spinal to intraoperative interval 10. Blood pressure (mmHg) during the post-spinal to intraoperative interval 11. Medication given to maintain blood pressure during the post- spinal to intraoperative interval Post operation time to: 12. First oral feed 13. First flatus 14. Resting pain score (day 1 before mobilisation) VNRS 0 to 10 15. Interval from surgery to ambulation 16. Maternal fever to discharge (>38°C) |
| Overall study start date | 01/10/2019 |
| Overall study end date | 24/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Patients planned for elective Caesarean section 2. Age of >18 years 3. Gestational age of >37 weeks 4. Receiving spinal anesthesia 5. Singleton pregnancy 6. Reassuring fetal status (normal fetal heart tracing) |
| Participant exclusion criteria | Current exclusion criteria as of 05/01/2021: 1. BMI >40 kg/m² 2. Placenta Praevia Major 3. Placenta accreta 4. Twins and multiple births 5. Emergency Caesarean sections 6. Patients in labour or having contractions 7. DM in pregnancy requiring insulin therapy 8. Anticipated significant risk of extended surgery (e.g intra-abdominal adhesions, myomectomy) 9. Anticipated significant conversion risk to general anaesthesia 10. Anticipated high risk of perioperative vomiting 11. Anticipated ICU admission 12. COVID-positive _____ Previous exclusion criteria: 1. BMI >40 kg/m² 2. Placenta Praevia Major 3. Placenta accreta 4. Twins and multiple births 5. Emergency Caesarean sections 6. Patients in labour or having contractions 7. DM in pregnancy requiring insulin therapy 8. Anticipated significant risk of extended surgery (e.g intra-abdominal adhesions, myomectomy) 9. Anticipated significant conversion risk to general anaesthesia 10. Anticipated high risk of perioperative vomiting 11. Anticipated ICU admission |
| Recruitment start date | 02/10/2020 |
| Recruitment end date | 10/05/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Sponsor information
University/education
Department of Obstetrics and Gynecology
University Malaya
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 03-7949 4422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
27/11/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 01/10/2020 to 02/10/2020.
2. The recruitment end date was changed from 01/10/2021 to 10/05/2022.
3. The overall study end date was changed from 30/03/2022 to 24/05/2022.
4. The intention to publish date was changed from 30/03/2023 to 31/12/2023.
23/11/2021: The following changes were made to the trial record:
1. The overall end date was changed from 01/12/2021 to 30/03/2022.
2. The intention to publish date was changed from 01/10/2022 to 30/03/2023.
3. The plain English summary was updated to reflect these changes.
05/01/2021: The following changes have been made:
1. The participant exclusion criteria have been changed.
2. The plain English summary has been updated to reflect the 29/12/2020 change to the intervention.
29/12/2020: The following changes have been made:
1. The intervention has been changed.
2. The primary outcome measures have been changed.
3. The secondary outcome measures have been changed.
02/10/2020: Internal review.
30/09/2020: Trial’s existence confirmed by University of Malaya.
