Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section (POC-NaVoP)

Pomeranian Medical University Szczecin

Status: Unknown

Conditions: Postoperative Nausea and Vomiting

Treatments: Dietary Supplement: preoperative oral carbohydrate, preOp

Study type: Interventional

Funder types: Other

Identifiers

NCT04069806

PUM_08.08.2019

Details and patient eligibility

About

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Full description

Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >=18 years.
2. Scheduled for an elective cesarean section.
3. Uncomplicated pregnancy.
4. Planned for spinal anesthesia.
5. ASA I or ASA II.

Exclusion criteria

1. History of diabetes.
2. History of gastro-intestinal reflux (GERD).
3. Unable or unwilling to sign an informed consent.
4. Contraindications to spinal anesthesia.
5. Contraindication to Oral carbohydrate formula.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Preoperative oral carbohydrate load

Experimental group

Description:

6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.

Treatment:

Dietary Supplement: preoperative oral carbohydrate, preOp

Standard preoperative fasting

No Intervention group

Description:

6 hours for solid food and 2 hours for liquids.