Nausea and vomiting associated with regional anesthesia during elective Caesarean section Surgery
Conditions
Interventions
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 t
Sponsors
University of Malaya
Eligibility
Sex/Gender
Female
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malaysia
Outcome results
None listed