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?

Not Applicable

Completed

• Conditions: ausea and vomiting associated with regional anesthesia during elective Caesarean section; Surgery

• Registration Number: ISRCTN63282932
• Lead Sponsor: niversity of Malaya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-01
• Study Completion: 2022-05-24
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 500

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

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

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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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 29/12/2020:<br> 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<br> 2. Patient satisfaction with the feeding strategy assessed on the day of discharge using a verbal numerical rating scale (VNRS) from 0 to 10<br><br> _____<br><br> Previous primary outcome measures:<br> 1. Vomiting intraoperative = yes or no (any vomiting from the time of entry to OT until 6 hours after the start of the surgery)<br> 2. Patient satisfaction – VNRS score 0 to 10 - assessed at day 1 post-operation<br>