Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2021-08-31

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.

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Preoperative oral carbohydrate load

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

Group Type EXPERIMENTAL

preoperative oral carbohydrate, preOp

Intervention Type DIETARY_SUPPLEMENT

Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.

Standard preoperative fasting

6 hours for solid food and 2 hours for liquids.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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preoperative oral carbohydrate, preOp

Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No