Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Dietary Supplement: preoperative oral carbohydrate, preOp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years. Scheduled for an elective cesarean section. Uncomplicated pregnancy. Planned for spinal anesthesia. ASA I or ASA II. Exclusion Criteria: History of diabetes. History of gastro-intestinal reflux (GERD). Unable or unwilling to sign an informed consent. Contraindications to spinal anesthesia. Contraindication to Oral carbohydrate formula.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative oral carbohydrate load<br>6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery. | Dietary Supplement: preoperative oral carbohydrate, preOp<br>* Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.<br>|
| No Intervention: Standard preoperative fasting<br>6 hours for solid food and 2 hours for liquids. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting 6 hours after caesarian section. | The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours). | 6 hours | 
| Postoperative nausea and vomiting 24 hours after caesarian section. | The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first peristalsis. | Moment of first peristalsis after operation (in hours). | 24 hours | 
| Time to first bowel movement. | Moment of first bowel movement after operation (in hours). | 24 hours | 
| Concentration of serum lactate in serum. | Lactate level measured in maternal serum. | 0 hours | 
| Concentration of beta-hydroxy-butiric acid in serum. | Beta-hydroxy-butiric acid level measured in maternal serum. | 0 hours | 
| Insulin resistance factor (HOMA-IR). | Insulin resistance measured in maternal serum. | 0 hours | 
| Concentration of isoprostane in urine. | Isoprostane level measured in maternal urine. | 0 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Oral carbohydrate, Fasting