Clinical trial NCT04069806: Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
Official title: An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Nausea
Vomiting
Oral carbohydrate
Fasting
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative nausea and vomiting 6 hours after caesarian section.
timeFrame: 6 hours
measure: Postoperative nausea and vomiting 24 hours after caesarian section.
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first peristalsis.
timeFrame: 24 hours
measure: Time to first bowel movement.
timeFrame: 24 hours
measure: Concentration of serum lactate in serum.
timeFrame: 0 hours
measure: Concentration of beta-hydroxy-butiric acid in serum.
timeFrame: 0 hours
measure: Insulin resistance factor (HOMA-IR).
timeFrame: 0 hours
measure: Concentration of isoprostane in urine.
timeFrame: 0 hours
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
Study officials:
affiliation: Pomeranian Medical University
name: Katarzyna L Kotfis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeranian Medical University
name: Sebastian Kwiatkowski, MD, PhD
role: STUDY_CHAIR
References: